VuPad Ophthalmic Ultrasound System - The VuPad AP Ophthalmic Ultrasound System is a - SONOMED, INC.

Duns Number:107037079

Device Description: The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that i 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.

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More Product Details

Catalog Number

AP.580

Brand Name

VuPad Ophthalmic Ultrasound System

Version/Model Number

VuPad AP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140199

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

0ac412c8-58cb-4414-ba9f-0080554d63ae

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONOMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23