Duns Number:085049749
Device Description: Image segmentation system for the transfer of imaging information from a medical scanner s Image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for surgical planning.
Catalog Number
PROcedure Rehearsal Studio
Brand Name
PROcedure Rehearsal Studio
Version/Model Number
2.0.1.
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"
-
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
K153705
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
77bf4113-8648-4da3-b316-89e0f9af50f7
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
September 23, 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. | 146 |