The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Syngo Inspace 4d.
| Device ID | K043469 |
| 510k Number | K043469 |
| Device Name: | SYNGO INSPACE 4D |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 Forchheim, DE 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 | 2004-12-16 |
| Decision Date | 2005-02-03 |
| Summary: | summary |