The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc. with the FDA for Syngo.ct Vascular Analysis.
| Device ID | K112020 |
| 510k Number | K112020 |
| Device Name: | SYNGO.CT VASCULAR ANALYSIS |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Ralf Hofmann |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-07-14 |
| Decision Date | 2011-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869026350 | K112020 | 000 |
| 04056869013886 | K112020 | 000 |
| 04056869007793 | K112020 | 000 |