InsightRT CDS IRT100
InsightRT CDS IRT100 is a radiation therapy software (FDA Class II; FDA product code MUJ, System,Planning,Radiation Therapy Treatment) made by Siris Medical, cleared under FDA 510(k) K151560 on 11 Sep 2015 and listed in FDA GUDID since 8 Aug 2016 (UDI-DI B244IRT1000), active as of 23 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 | NumberB244IRT1000 | Date8 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151560 | Date11 Sep 2015 | StatusActive |
Official records
- FDA 510(k) database K151560
Across registries
- FDA 510(k) K151560 decided 11 Sep 2015 Active
- FDA GUDID UDI-DI B244IRT1000 listed 8 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K151560
- Listed FDA GUDID B244IRT1000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- InsightRT CDS
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- IRT100
- Primary DI / UDI-DI
- B244IRT1000
- 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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