sonomedescalon.com
sonomedinc.comAXIS Image Management System
Sonomed, Inc.
SONOMED, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2433682 | 2433682 | SONOMED, INC. | 1 | N | 2026-01-01 | 865 Merrick Ave Ste 30s Westbury NY US 11590 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00896100002002 | AXIS Image Management System - Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud. | 516-354-0900 | info@sonomedescalon.com |
| 00896100002019 | VuPad Ophthalmic Ultrasound System - The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator manual. | 800-227-1285 | info@sonomedinc.com |
| 00896100002026 | VuPad Ophthalmic Ultrasound System - The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad BP is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers.The system is provided with the portable B-Scan tablet, 12 MHz B-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual. | 800-227-1285 | info@sonomedinc.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 37541 | 1621820329 | K171098 | AXIS Image Management System | NFJ | 2017-05-02 |
| 37541 | 1754159646 | K140199 | VUPAD | IYO | 2014-04-01 |
| 37541 | 1599503694 | K100252 | MASTER-VU A-SCAN, MV4500 | IYO | 2010-04-09 |
| 37541 | 1017793229 | K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | ITX | 2009-09-24 |
| 37541 | 1755342406 | K073196 | MASTER-VU | IYO | 2007-12-19 |
| 37541 | 1042720022 | K060626 | VUMAX | IYO | 2006-04-11 |
| 37541 | 1550819784 | K040668 | E-Z SCAN AB5500+ | IYO | 2004-04-13 |
| 37541 | 1450138996 |
Product Codes Associated With Registrations#
PMN#
VUPAD
SONOMED, INC.
MASTER-VU A-SCAN, MV4500
SONOMED, INC.
PACSCAN PLUS, MODELS 300P AND 300AP
SONOMED, INC.
MASTER-VU
SONOMED, INC.
VUMAX
SONOMED, INC.
E-Z SCAN AB5500+
SONOMED, INC.
CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL
SONOMED TECHNOLOGY, INC.
SONOQUICK ULTRASOUND GEL
SONOMED TECHNOLOGY, INC.
SONOMED 4000P ULTRASONIC PACHYMETER
SONOMED, INC.
NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT
SONOMED TECHNOLOGY, INC.
SONOMED TECH OPHTHALMIC B-SCAN B-3000
SONOMED TECHNOLOGY, INC.
OPHTHALMIC A-SCAN A-2000 SONOME
SONOMED TECHNOLOGY, INC.
GUDID#
AXIS Image Management System - Software application for ophthalmic image management system with a browser-based interface for image review and analysis of ophthalmic images. Software utilizing available data from ophthalmic devices to provide views and tools that are clinically useful in helping to diagnose and monitor. A picture archiving and communication system to allow storage, retrieval, analysis, and management of digital images of the eye. Provides integration of different ophthalmic devices for any imaging modality. Complaint with DICOM interoperability standard and can integrate any DICOM-compliant device, including using DICOM modality worklists. Axis can integrate non-DICOM devices to provide data and imaging regardless of device type. Can be integrated with any EHR system via HL7 interface or other means. Functionality and access to images can be from AXIS server or AXIS cloud.
2022-03-21
VuPad Ophthalmic Ultrasound System - The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad BP Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad BP is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers.The system is provided with the portable B-Scan tablet, 12 MHz B-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad A/B/P Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes A-Scan, B-Scan and pachymeter capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable tablet, 12 MHz B-probe, 10 MHz A-probe, 20 MHz pachymetry probe, power supply, foot switch and user manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable UBM tablet, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan, UBM (high frequency B-scan), and pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe, power supply, foot switch and user manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, UBM (high frequency B-scan),a nd pachymetry. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The pachymeter measures the central corneal thickness of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual.
2020-12-07
VuPad Ophthalmic Ultrasound System - The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad B-Scan is a multi-purpose, computer-based,ultrasonic diagnostic system that produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers.The system is provided with the portable B-Scan tablet, 12 MHz B-probe, built-in probe holder, foot switch and user manual.
2016-08-10
VuPad Ophthalmic Ultrasound System - The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable A/B-scan tablet, 12 MHz B-probe, 10 MHz A-probe, built-in probe holders, foot switch and user manual.
2016-08-10
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicroscopy device intended for use in ophthalmic applications.The ultrasound probe with the system is a water path probe with 35 MHz transducer providing high resolution images. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable UBM tablet, water-path probe with 35 MHz transducer, built-in probe holder, foot switch and user manual.
2016-08-10
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual.
2016-08-10
VuPad Ophthalmic Ultrasound System - The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for A-Scan, B-Scan, and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable A/B/UBM tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual.
2016-08-10
VuPad Ophthalmic Ultrasound System - The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The VuPad A-Scan system includes the portable A-Scan tablet, a 10 MHz A-probe, built-in probe holder, foot switch and operator manual.
2016-08-10
PacScan 300 Plus Ophthalmic Ultrasound - "The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The PacScan 300A+ system includes a 6"" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, foot switch and operator manual."
2016-08-10
PacScan 300 Plus Ophthalmic Ultrasound - "The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The system integrates A-Scan and Pachymeter capabilities into a single system. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The pachymeter is a biometric device that allows for measuring and mapping corneal thickness. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The pachymeter uses a higher frequency signal to measure shorter distances. The PacScan 300AP+ system includes a 6"" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, 20 MHz Pachymeter probe, foot switch and operator manual."
2016-08-10
Master-Vu A-Scan Ophthalmic Ultrasound System - The Master-Vu A-Scan Ophthalmic Ultrasound System is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The Master-Vu A-Scan can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The Master-Vu A-Scan system includes the A-Scan console, a 10 MHz A-probe, foot switch, flash drive with A-scan software, USB cable, carry case and operator manual.
2016-08-10
Master-Vu B-Scan Ophthalmic Ultrasound System - The Master-Vu B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye. They system consists of a sealed, posterior segment B-probe and cable designed to interface with any standard personal computer (host PC). The probe utilizes a 12 MHz transducer with a sector scanning probe operating on the host PC. The software for the Master-Vu B-Scan allows the host PC to function as the main control interface and display for the B-scan system. The system is provided with the portable, hand-held B-probe with 12 MHz transducer, USB cable, Master-Vu B software on a flash drive, carry case and user manual.
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active,device for imaging ocular features for diagnostic purposes.The B-scan mode ultilizes a sealed 12 MHz B-probe with a focused transducer. The system operates on a computer-based platform. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, 12 MHz B-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It utilizes a 35 MHz and/or 50 MHz transducer with a sector scanning probe. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the high frequency ultrasound system (UBM) including the base unit, 22"" LCD, water-path probe, 35 MHz transducer, keyboard and mouse, USB foot switch, immersion cups and user manual."
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, 12 MHz B-probe, 10 MHz A-probe, keyboard and mouse, USB foot switch, and user manual."
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes ultilizing a 35 MHz and/or 50 MHz transducer with a sector scanning probe and operates on a computer-based platform. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, 10 mHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes.The B-scan modes ultilizes a sealed 12 MHz B-probe with a focused transducer and a water path probe with 35 MHz and/or 50 MHz transducer. Th system operates on a computer-based platform. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, water-path probe with 35 MHz transducer, 12 MHz B-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
2016-08-10
VuMAX HD Ophthalmic Ultrasound System - "The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, bio-microscope (UBM) device for imaging ocular features for diagnostic purposes.The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. The system operates on a computer-based platform. UBM capabilities include sulcus-to-sulcus, angle detail, high resolution, and motion picture settings. The system includes the multi-frequency ultrasound system base unit, 22"" LCD, water-path probe with 35 MHz transducer, 10 MHz A-probe, keyboard and mouse, USB foot switch, immersion cups and user manual."
2017-03-27