The following data is part of a premarket notification filed by Reflexion Medical, Inc. with the FDA for Reflexion Medical Radiotherapy System.
| Device ID | K190978 |
| 510k Number | K190978 |
| Device Name: | RefleXion Medical Radiotherapy System |
| Classification | Accelerator, Linear, Medical |
| Applicant | RefleXion Medical, Inc. 25841 Industrial Blvd, Suite 275 Hayward, CA 94545 |
| Contact | Kathy O’shaughnessy |
| Correspondent | Kathy O’shaughnessy RefleXion Medical, Inc. 25841 Industrial Blvd, Suite 275 Hayward, CA 94545 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2020-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003983805 | K190978 | 000 |