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
- 2.0.1 FDA UDI
- Description
- Secondary Dose Check for external beam radiation therapy. FDA UDI
Identifiers
- Catalog Number
- TK2010, TK2020 FDA UDI
- Primary DI / UDI-DI
- B501THINKQA0200010 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 UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231573 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dosisoft SA
Sources (1)
- FDA UDI 40848cc6-4042-4975-ba64-3267fb5ae0b6 35 fields · synced May 30, 2026