Duns Number:962613332
Device Description: Anatomage Table is a volumetric imaging software designed specifically for clinicians, doc Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are to able examine anatomy on a computer screen and use software tools to move and manipulate rendered images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either a touch interface or standard mouse and keyboard interactions.
Catalog Number
-
Brand Name
Anatomage Table
Version/Model Number
5.0.1
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"
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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
K140093
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
1318f4dd-3a3b-47c6-bd55-91fcedfbe130
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 30, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |