InVivo Web Viewer - InVivo Web Viewer is a software application used - ANATOMAGE, INC.

Duns Number:962613332

Device Description: InVivo Web Viewer is a software application used for the display and 3D visualization of m InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI.

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More Product Details

Catalog Number

-

Brand Name

InVivo Web Viewer

Version/Model Number

1.0

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

K123519

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

ee9ad105-06af-4814-bcab-9be3e7764d59

Public Version Date

March 29, 2019

Public Version Number

1

DI Record Publish Date

March 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANATOMAGE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7