K242919 is an FDA 510(k) clearance for the V5med Lung AI. This device is classified as a Lung Computed Tomography System, Computer-aided Detection (Class II - Special Controls, product code OEB).
Submitted by V5med, Inc. (Hsinchu County, TW). The FDA issued a Cleared decision on March 27, 2025, 184 days after receiving the submission on September 24, 2024.
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 | K242919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2024 |
| Decision Date | March 27, 2025 |
| Days to Decision | 184 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. |