The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Lung Cad.
| Device ID | K063877 |
| 510k Number | K063877 |
| Device Name: | SYNGO LUNG CAD |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Morteza Minaee |
| Correspondent | Morteza Minaee SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-12 |
| Decision Date | 2006-10-18 |