The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo Ct Dynamic Angio.
| Device ID | K120331 |
| 510k Number | K120331 |
| Device Name: | SYNGO CT DYNAMIC ANGIO |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE D-91052 |
| Contact | Ralf Hofmann |
| 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 | 2012-02-02 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026404 | K120331 | 000 |
| 04056869013930 | K120331 | 000 |
| 04056869007847 | K120331 | 000 |