K250716 is an FDA 510(k) clearance for the IMAGE ONE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Infomed Software, S.L. (Barcelona, ES). The FDA issued a Cleared decision on July 23, 2025, 135 days after receiving the submission on March 10, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K250716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2025 |
| Decision Date | July 23, 2025 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |