K113360 is an FDA 510(k) clearance for the MEDICAL IMAGE PROCESSING UNIT. This device is classified as a Unit, X-ray, Intraoral (Class II - Special Controls, product code EAP).
Submitted by Humanray Co,Ltd (Houston, US). The FDA issued a Cleared decision on February 7, 2012, 85 days after receiving the submission on November 14, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1810.
| 510(k) Number | K113360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2011 |
| Decision Date | February 07, 2012 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EAP — Unit, X-ray, Intraoral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1810 |