The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo.ct Coronary Analysis.
| Device ID | K100637 |
| 510k Number | K100637 |
| Device Name: | SYNGO.CT CORONARY ANALYSIS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 Forchheim, DE 91301 |
| Contact | Ralf Hofmann |
| Correspondent | Stefan Preiss 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 | 2010-03-05 |
| Decision Date | 2010-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026329 | K100637 | 000 |
| 04056869013855 | K100637 | 000 |
| 04056869007762 | K100637 | 000 |