The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo.ct Cardiac Planning.
| Device ID | K170221 |
| 510k Number | K170221 |
| Device Name: | Syngo.CT Cardiac Planning |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Siemens Healthcare GmbH Siemensstr. 1 Forchheim, DE 91301 |
| Contact | Martin Knoppik |
| Correspondent | George Bauer 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 | 2017-01-25 |
| Decision Date | 2017-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026503 | K170221 | 000 |