The following data is part of a premarket notification filed by Siemens Ag with the FDA for Syngo.ct Cardiac Function.
| Device ID | K110366 |
| 510k Number | K110366 |
| Device Name: | SYNGO.CT CARDIAC FUNCTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG 51 VALLEY STREAM PKWY Malvern, PA 19355 |
| Contact | Ralf Hoffmann |
| Correspondent | Norbert Stuiber TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-07 |
| Decision Date | 2011-04-12 |
| Summary: | summary |