The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Enhanced Imaging System.
| Device ID | K041166 |
| 510k Number | K041166 |
| Device Name: | SIEMENS ENHANCED IMAGING SYSTEM |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Frank Pokrop |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-04 |
| Decision Date | 2004-05-17 |
| Summary: | summary |