The following data is part of a premarket notification filed by Siemens Medical Solutions, Inc with the FDA for Syngo.ct Lung Cad.
| Device ID | K193216 |
| 510k Number | K193216 |
| Device Name: | Syngo.CT Lung CAD |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | Siemens Medical Solutions, Inc 65 Valley Stream Parkway Malvern, PA 19355 |
| Contact | Abhineet Johri |
| Correspondent | Abhineet Johri Siemens Medical Solutions, Inc 65 Valley Stream Parkway Malvern, PA 19355 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-21 |
| Decision Date | 2020-03-09 |