The following data is part of a premarket notification filed by Chimaera Gmbh with the FDA for Fusionsync, Chimaera Fusionsync.
| Device ID | K132963 |
| 510k Number | K132963 |
| Device Name: | FUSIONSYNC, CHIMAERA FUSIONSYNC |
| Classification | System, Image Processing, Radiological |
| Applicant | CHIMAERA GMBH AM WEICHSELGARTEN 7 Erlangen, Bavaria, DE 91058 |
| Contact | Marcus Pruemmer |
| Correspondent | Marcus Pruemmer CHIMAERA GMBH AM WEICHSELGARTEN 7 Erlangen, Bavaria, DE 91058 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-20 |
| Decision Date | 2013-12-16 |
| Summary: | summary |