The following data is part of a premarket notification filed by Siemens Ag with the FDA for Syngo Neuro Dsa Ct.
| Device ID | K053024 |
| 510k Number | K053024 |
| Device Name: | SYNGO NEURO DSA CT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG SIEMENSSTR. 1 Forchheim, DE D-91301 |
| Contact | Ruediger Koerner |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 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 | 2005-10-21 |
| Decision Date | 2005-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869013916 | K053024 | 000 |
| 04056869007823 | K053024 | 000 |