XVlite - Dental imaging capture, enhance and display - APTERYX INC

Duns Number:958821886

Device Description: Dental imaging capture, enhance and display software.

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More Product Details

Catalog Number

-

Brand Name

XVlite

Version/Model Number

3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

dd1f39de-fde4-461c-834f-5f43fdf1a5c0

Public Version Date

December 31, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APTERYX INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6