The following data is part of a premarket notification filed by Siemens Ag, Medical Solutions with the FDA for Lungcare Ct Software Package With Extended Functionality.
| Device ID | K033374 |
| 510k Number | K033374 |
| Device Name: | LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | SIEMENS AG, MEDICAL SOLUTIONS SIEMENSSTRASSE 1 Forchheim, DE D 91301 |
| Contact | Rudiger Korner |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2003-11-06 |
| Summary: | summary |