VuPad Ophthalmic Ultrasound System BU.580

GUDID 00896100002156

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.

SONOMED, INC.

Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system Ophthalmic ultrasound imaging system
Primary Device ID00896100002156
NIH Device Record Key3bc12bd0-eb4d-4eda-8472-e859a3ec362b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVuPad Ophthalmic Ultrasound System
Version Model NumberVuPad B/UBM
Catalog NumberBU.580
Company DUNS107037079
Company NameSONOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com
Phone800-227-1285
Emailinfo@sonomedinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]
GS100896100002156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-23
Device Publish Date2016-08-10

On-Brand Devices [VuPad Ophthalmic Ultrasound System]

00896100002170The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non
00896100002163The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
00896100002156The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric devic
00896100002149The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic, ultrasound biomicr
00896100002132The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biomet
00896100002125The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometri

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