ThinkQA Edition 2 2.0.1
by Dosisoft
ThinkQA Edition 2 2.0.1 is a Class II device made by Dosisoft, cleared under FDA 510(k) K231573 on 18 Jan 2024 and listed in FDA GUDID since 14 Aug 2024 (UDI-DI B501THINKQA0200010), 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 | NumberB501THINKQA0200010 | Date14 Aug 2024 | StatusListed |
| United States | FDA 510(k) | NumberK231573 | Date18 Jan 2024 | StatusActive |
Official records
- FDA 510(k) database K231573
Across registries
- FDA 510(k) K231573 decided 18 Jan 2024 Active
- FDA GUDID UDI-DI B501THINKQA0200010 listed 14 Aug 2024 Listed
Timeline
- Cleared FDA 510(k) K231573
- Listed FDA GUDID B501THINKQA0200010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ThinkQA Edition 2
- Generic name
- Radiation therapy software
- Model / Ref / Catalog
- 2.0.1, TK2010, TK2020
- Primary DI / UDI-DI
- B501THINKQA0200010
- 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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