K213646 is an FDA 510(k) clearance for the Focus HD 35 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 Iray Technology Taicang , Ltd. (Taicang, CN). The FDA issued a Cleared decision on March 29, 2022, 145 days after receiving the submission on November 4, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K213646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2021 |
| Decision Date | March 29, 2022 |
| Days to Decision | 145 days |
| Submission Type | Special |
| 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 |