Duns Number:264815932
Device Description: PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy respon PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
Catalog Number
3.1.1
Brand Name
PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose
Version/Model Number
3.1.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K182966
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
01d4e834-568d-4d18-a660-a3d8d2646868
Public Version Date
February 07, 2020
Public Version Number
1
DI Record Publish Date
January 30, 2020
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. | 6 |