K241346 is an FDA 510(k) clearance for the IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector). This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Aspen Imaging Healthcare, Inc. (Plano, US). The FDA issued a Cleared decision on November 7, 2024, 178 days after receiving the submission on May 13, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K241346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2024 |
| Decision Date | November 07, 2024 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |