The following data is part of a premarket notification filed by Keosys Sas with the FDA for Advanced Medical Imaging Software Suite (kswvwr).
| Device ID | K160334 |
| 510k Number | K160334 |
| Device Name: | Advanced Medical Imaging Software Suite (KSWVWR) |
| Classification | System, Image Processing, Radiological |
| Applicant | KEOSYS SAS 13 Impasse Serge Reggiani Saint Herblain, FR 44815 |
| Contact | Laurence Boy-machefer |
| Correspondent | Laurence Boy-machefer KEOSYS SAS 13 Impasse Serge Reggiani 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 | 2016-02-08 |
| Decision Date | 2016-06-21 |
| Summary: | summary |