The following data is part of a premarket notification filed by Humanray Co,ltd with the FDA for Medical Image Processing Unit.
| Device ID | K113360 |
| 510k Number | K113360 |
| Device Name: | MEDICAL IMAGE PROCESSING UNIT |
| Classification | Unit, X-ray, Intraoral |
| Applicant | HUMANRAY CO,LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Contact | Dave Kim |
| Correspondent | Dave Kim HUMANRAY CO,LTD 12946 KIMBERLEY LN Houston, TX 77079 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-14 |
| Decision Date | 2012-02-07 |
| Summary: | summary |