The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Colongraphy Software Package With Extended Functionality.
| Device ID | K042605 |
| 510k Number | K042605 |
| Device Name: | COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
| Classification | Colon Computed Tomography System, Computer Aided Detection |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS HENKESTRASSE 127 Erlangen, DE 91052 |
| Contact | Rudiger Korner |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | NWE |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2004-10-08 |
| Summary: | summary |