ThinkQA, EPIbeam 1.0.2
by Dosisoft
ThinkQA, EPIbeam 1.0.2 is a Class II device made by Dosisoft, cleared under FDA 510(k) K180106 on 13 Mar 2018 and listed in FDA GUDID since 18 Apr 2018 (UDI-DI B501THINKQA010002), active as of 12 Nov 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 | NumberB501THINKQA010002 | Date18 Apr 2018 | StatusListed |
| United States | FDA 510(k) | NumberK180106 | Date13 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K180106
Across registries
- FDA 510(k) K180106 decided 13 Mar 2018 Active
- FDA GUDID UDI-DI B501THINKQA010002 listed 18 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K180106
- Listed FDA GUDID B501THINKQA010002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ThinkQA, EPIbeam
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- 1.0.2
- Primary DI / UDI-DI
- B501THINKQA010002
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiation therapy software
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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