K220961 is an FDA 510(k) clearance for the Deep Learning Image Reconstruction. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Ge Healthcare Japan Corporation (Hino, JP). The FDA issued a Cleared decision on July 29, 2022, 119 days after receiving the submission on April 1, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K220961 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2022 |
| Decision Date | July 29, 2022 |
| Days to Decision | 119 days |
| Submission Type | Special |
| 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 |