K203258 is an FDA 510(k) clearance for the syngo.CT Lung CAD. This device is classified as a Lung Computed Tomography System, Computer-aided Detection (Class II - Special Controls, product code OEB).
Submitted by Siemens Healthcare GmbH (Forchheim, DE). The FDA issued a Cleared decision on March 31, 2021, 146 days after receiving the submission on November 5, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr..
| 510(k) Number | K203258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2020 |
| Decision Date | March 31, 2021 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OEB — Lung Computed Tomography System, Computer-aided Detection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr. |