The following data is part of a premarket notification filed by Leoni Cia Cable System with the FDA for Leoni Orion System.
| Device ID | K160518 |
| 510k Number | K160518 |
| Device Name: | LEONI ORION System |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | LEONI CIA CABLE SYSTEM 5 AVE VICTOR HUGO Chartres, FR 28000 |
| Contact | Aurelie Genho |
| Correspondent | Aurelie Genho LEONI CIA CABLE SYSTEM 5 AVE VICTOR HUGO Chartres, FR 28000 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700383510178 | K160518 | 000 |
| 03700383510154 | K160518 | 000 |
| 03700383510086 | K160518 | 000 |
| 03700383510079 | K160518 | 000 |
| 03700383510048 | K160518 | 000 |
| 03700383510031 | K160518 | 000 |
| 03700383510017 | K160518 | 000 |
| 03700383510000 | K160518 | 000 |