The following data is part of a premarket notification filed by Qualiformed Sarl with the FDA for Linacwatch, Linacview.
| Device ID | K172534 |
| 510k Number | K172534 |
| Device Name: | LINACwatch, LinacView |
| Classification | Accelerator, Linear, Medical |
| Applicant | QualiFormeD Sarl 14 Rue De La Vieille Horloge La Roche Sur Yon, FR 85000 |
| Contact | Stephane Beaumont |
| Correspondent | Thomas Kroenke Speek To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-22 |
| Decision Date | 2017-10-27 |
| Summary: | summary |