FDA.reportPublic FDA data

VuPad Ophthalmic Ultrasound System

Primary DI
00896100002026
Brand
VuPad Ophthalmic Ultrasound System
Company
SONOMED, INC.
Model
VuPad BP
Catalog number
BP.580
Device description
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.
Published
2020-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140199000VUPADSonomed, Inc.2014-04-01IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00896100002026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00896100002026008961000020268961000020260896100002026

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic ultrasound imaging systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-227-1285info@sonomedinc.com

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 DIBrandModelCatalogPublished
00896100002002AXIS Image Management SystemVer 5Axis2022-03-21
00896100002019VuPad Ophthalmic Ultrasound SystemVuPad APAP.5802020-12-07
00896100002033VuPad Ophthalmic Ultrasound SystemVuPad A/B/PBAP.5802020-12-07
00896100002040VuPad Ophthalmic Ultrasound SystemVuPad UBM/PUP.5802020-12-07
00896100002057VuPad Ophthalmic Ultrasound SystemVuPad B/UBM/PBUP.5802020-12-07
00896100002064VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBM/PBUAP.5802020-12-07
00896100002125VuPad Ophthalmic Ultrasound SystemVuPad BB.5802016-08-10
00896100002132VuPad Ophthalmic Ultrasound SystemVuPad A/BBA.5802016-08-10
00896100002149VuPad Ophthalmic Ultrasound SystemVuPad UBMU.5802016-08-10
00896100002156VuPad Ophthalmic Ultrasound SystemVuPad B/UBMBU.5802016-08-10
00896100002163VuPad Ophthalmic Ultrasound SystemVuPad A/B/UBMBUA.5802016-08-10
00896100002170VuPad Ophthalmic Ultrasound SystemVuPad AA.5802016-08-10
00896100002088PacScan 300 Plus Ophthalmic Ultrasound300A+ A-Scan Only300A+2016-08-10
00896100002095PacScan 300 Plus Ophthalmic Ultrasound300AP+ A-Scan/Pachymeter300AP+2016-08-10
00896100002101Master-Vu A-Scan Ophthalmic Ultrasound SystemMV4500MV45002016-08-10
00896100002118Master-Vu B-Scan Ophthalmic Ultrasound SystemMV5600MV56002016-08-10
00896100002187VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD B ScanB.5752016-08-10
00896100002194VuMAX HD Ophthalmic Ultrasound SystemVuMAX-HD UBMU.5752016-08-10
00896100002200VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD A/BBA.5752016-08-10
00896100002217VuMAX HD Ophthalmic Ultrasound SystemVuMAX HD A/B/UBMBUA.5752016-08-10

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