Smart Segmentation - Knowledge Based Contouring 15.0
by Varian Medical Systems Imaging Laboratory GmbH
Smart Segmentation - Knowledge Based Contouring 15.0 is a Class II device made by Varian Medical Systems Imaging Laboratory GmbH, cleared under FDA 510(k) K141248 on 5 Sep 2014 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00856100006011), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856100006011 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141248 | Date5 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00856100006011
- FDA 510(k) database K141248
Across registries
- FDA 510(k) K141248 decided 5 Sep 2014 Active
- FDA GUDID UDI-DI 00856100006011 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141248
- Listed FDA GUDID 00856100006011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smart Segmentation - Knowledge Based Contouring
- Generic name
- Radiation therapy software
- Model / reference
- 15.0
- Primary DI / UDI-DI
- 00856100006011
- 510(k) Number
- FDA product code
- MUJ
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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