K120388 is an FDA 510(k) clearance for the INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on April 6, 2012, 59 days after receiving the submission on February 7, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K120388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2012 |
| Decision Date | April 06, 2012 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OXO — Image-intensified Fluoroscopic X-ray System, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Fluoroscopy Of The Human Body. |