K240369 is an FDA 510(k) clearance for the CAC (gated) Algorithm. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by BunkerHill Health (San Francisco, US). The FDA issued a Cleared decision on September 27, 2024, 233 days after receiving the submission on February 7, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K240369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2024 |
| Decision Date | September 27, 2024 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |