VuMAX HD Ophthalmic Ultrasound System - The VuMAX HD Ophthalmic Ultrasound System is a - SONOMED, INC.

Duns Number:107037079

Device Description: The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging o The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22" LCD, 12 MHz B-probe, 10 MHz A-probe, keyboard and mouse, USB foot switch, and user manual.

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More Product Details

Catalog Number

BA.575

Brand Name

VuMAX HD Ophthalmic Ultrasound System

Version/Model Number

VuMAX HD A/B

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

K060626

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

a520e9b0-a580-4f22-9f34-8b9b8645676f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

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