K260169 is an FDA 510(k) clearance for the AV Cardiac CT. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on March 5, 2026, 44 days after receiving the submission on January 20, 2026.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K260169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2026 |
| Decision Date | March 05, 2026 |
| Days to Decision | 44 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 |