VuPad Ophthalmic Ultrasound System A.580

GUDID 00896100002170

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.

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 ID00896100002170
NIH Device Record Key0adfd437-1365-4d95-8a00-968f3a1036e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVuPad Ophthalmic Ultrasound System
Version Model NumberVuPad A
Catalog NumberA.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
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [Primary]
GS100896100002170 [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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