K121444 is an FDA 510(k) clearance for the FLAT PANEL DETECTOR. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Canon, Inc. - Medical Equpment Group (Richardson, US). The FDA issued a Cleared decision on June 7, 2012, 23 days after receiving the submission on May 15, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K121444 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2012 |
| Decision Date | June 07, 2012 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |