The following data is part of a premarket notification filed by Keosys S.a.s. with the FDA for Imagys.
| Device ID | K102000 |
| 510k Number | K102000 |
| Device Name: | IMAGYS |
| Classification | System, Image Processing, Radiological |
| Applicant | KEOSYS S.A.S. IMPASSE AUGUSTIN FRESNEL, Z.A. DU MOULIN NEUF B.P. 227 Saint-herblain, FR 44815 |
| Contact | Anthony Mottier |
| Correspondent | Anthony Mottier KEOSYS S.A.S. IMPASSE AUGUSTIN FRESNEL, Z.A. DU MOULIN NEUF B.P. 227 Saint-herblain, FR 44815 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-10-12 |
| Summary: | summary |