Catalog Number

Visix for Intraoral Camera 2.3.10

Brand Name

Visix

Version/Model Number

for Intraoral Camera 2.3.10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K082623

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

69d42719-b1f0-4d37-898d-4ce2f01d2a15

Public Version Date

May 23, 2019

Public Version Number

6

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-