Home GUDID 00896100002095 PacScan 300 Plus Ophthalmic Ultrasound
Primary DI 00896100002095
Brand PacScan 300 Plus Ophthalmic Ultrasound
Company SONOMED, INC.
Model 300AP+ A-Scan/Pachymeter
Catalog number 300AP+
Device description "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."
Published 2016-08-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00896100002095 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00896100002095 00896100002095 896100002095 0896100002095
GMDN Terms# Term, Definition table Term Definition Ophthalmic ultrasound imaging system An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.
Regulatory Flags# DUNS number 107037079 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00896100002002 AXIS Image Management System Ver 5 Axis 2022-03-21 00896100002019 VuPad Ophthalmic Ultrasound System VuPad AP AP.580 2020-12-07 00896100002026 VuPad Ophthalmic Ultrasound System VuPad BP BP.580 2020-12-07 00896100002033 VuPad Ophthalmic Ultrasound System VuPad A/B/P BAP.580 2020-12-07 00896100002040 VuPad Ophthalmic Ultrasound System VuPad UBM/P UP.580 2020-12-07 00896100002057 VuPad Ophthalmic Ultrasound System VuPad B/UBM/P BUP.580 2020-12-07 00896100002064 VuPad Ophthalmic Ultrasound System VuPad A/B/UBM/P BUAP.580 2020-12-07 00896100002125 VuPad Ophthalmic Ultrasound System VuPad B B.580 2016-08-10 00896100002132 VuPad Ophthalmic Ultrasound System VuPad A/B BA.580 2016-08-10 00896100002149 VuPad Ophthalmic Ultrasound System VuPad UBM U.580 2016-08-10 00896100002156 VuPad Ophthalmic Ultrasound System VuPad B/UBM BU.580 2016-08-10 00896100002163 VuPad Ophthalmic Ultrasound System VuPad A/B/UBM BUA.580 2016-08-10 00896100002170 VuPad Ophthalmic Ultrasound System VuPad A A.580 2016-08-10 00896100002088 PacScan 300 Plus Ophthalmic Ultrasound 300A+ A-Scan Only 300A+ 2016-08-10 00896100002101 Master-Vu A-Scan Ophthalmic Ultrasound System MV4500 MV4500 2016-08-10 00896100002118 Master-Vu B-Scan Ophthalmic Ultrasound System MV5600 MV5600 2016-08-10 00896100002187 VuMAX HD Ophthalmic Ultrasound System VuMAX HD B Scan B.575 2016-08-10 00896100002194 VuMAX HD Ophthalmic Ultrasound System VuMAX-HD UBM U.575 2016-08-10 00896100002200 VuMAX HD Ophthalmic Ultrasound System VuMAX HD A/B BA.575 2016-08-10 00896100002217 VuMAX HD Ophthalmic Ultrasound System VuMAX HD A/B/UBM BUA.575 2016-08-10
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