The following data is part of a premarket notification filed by Dosisoft with the FDA for Thinkqa.
| Device ID | K180106 |
| 510k Number | K180106 |
| Device Name: | ThinkQA |
| Classification | Accelerator, Linear, Medical |
| Applicant | DOSIsoft 45/47, Avenue Carnot Cachan, FR 94230 |
| Contact | Marc Uszynski |
| Correspondent | Luc Diot DOSIsoft 45/47, Avenue Carnot Cachan, FR 94230 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B501THINKQA010002 | K180106 | 000 |
| B501THINKQA010006 | K180106 | 000 |