Duns Number:707188131
Device Description: It is used by radiation oncology department to segment (non-contrast) CT images, to genera It is used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Catalog Number
-
Brand Name
RT-Mind-AI
Version/Model Number
V1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2027
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
K213155
Product Code
QKB
Product Code Name
Radiological Image Processing Software For Radiation Therapy
Public Device Record Key
b415a300-67ae-44cd-92e8-28b5fbe2a204
Public Version Date
March 23, 2022
Public Version Number
1
DI Record Publish Date
March 15, 2022
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. | 1 |