The following data is part of a premarket notification filed by Dosisoft with the FDA for Planet Onco Dose.
| Device ID | K182966 |
| 510k Number | K182966 |
| Device Name: | PLANET Onco Dose |
| Classification | System, Image Processing, Radiological |
| 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 | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B501PLANET030101 | K182966 | 000 |