ThinkQA, EPIbeam 1.0.4
by Dosisoft
ThinkQA, EPIbeam 1.0.4 is a Class II device made by Dosisoft, cleared under FDA 510(k) K180106 on 13 Mar 2018, registered in EUDAMED and listed in FDA GUDID since 7 Aug 2019 (UDI-DI B501THINKQA010004), active as of 12 Nov 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | NumberB501THINKQA010004 | Date7 Aug 2019 | StatusListed |
| United States | FDA 510(k) GUDID | NumberK180106 | Date13 Mar 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K180106 decided 13 Mar 2018 Active
- EUDAMED Active
- FDA GUDID UDI-DI B501THINKQA010004 listed 7 Aug 2019 Listed
Timeline
- Cleared FDA 510(k) K180106
- Listed FDA GUDID B501THINKQA010004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ThinkQA, EPIbeam
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- 1.0.4
- Primary DI / UDI-DI
- B501THINKQA010004
- 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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