The following data is part of a premarket notification filed by Micropos Medical Ab with the FDA for Raypilot System.
| Device ID | K203722 |
| 510k Number | K203722 |
| Device Name: | RayPilot System |
| Classification | Accelerator, Linear, Medical |
| Applicant | Micropos Medical AB Adolf Edelsvards Gata 11 Gothenburg, SE Se414 51 |
| Contact | Thomas Lindstrom |
| Correspondent | Hanna Syren Micropos Medical AB Adolf Edelsvards Gata 11 Gothenburg, SE Se414 51 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-21 |
| Decision Date | 2021-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350007956040 | K203722 | 000 |
| 07350007951052 | K203722 | 000 |
| 07350007952219 | K203722 | 000 |
| 07350007953049 | K203722 | 000 |
| 07350007954053 | K203722 | 000 |
| 07350007954060 | K203722 | 000 |
| 07350007954077 | K203722 | 000 |
| 07350007956019 | K203722 | 000 |
| 07350007956033 | K203722 | 000 |
| 07350007951045 | K203722 | 000 |