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ThinkQA Edition 2
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K231573
by Dosisoft SA
Identity
- Trade Name
- ThinkQA Edition 2 FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Secondary Dose Check for external beam radiation therapy. FDA UDI
- Model / Reference
- 2.0.0 FDA UDI
- Description
- Secondary Dose Check for external beam radiation therapy. FDA UDI
Identifiers
- Catalog Number
- TK2010, TK2020 FDA UDI
- Primary DI / UDI-DI
- B501THINKQA0200000 FDA UDI
- 510(k) Number
- K231573 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy software
ThinkQA Edition 2 by Dosisoft SA — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K231573 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231573 | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Dosisoft SA
Sources (3)
- FDA UDI 7372dc0b-6924-4673-ac6d-3d046e68d7a7 59 fields · synced Jun 18, 2026
- FDA 510(k) K231573 1 fields · synced Jun 5, 2026
- EUDAMED 1 fields · synced Jun 2, 2026