The following data is part of a premarket notification filed by Mediface Co., Ltd. with the FDA for Mediface Pacs.
| Device ID | K010259 |
| 510k Number | K010259 |
| Device Name: | MEDIFACE PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDIFACE CO., LTD. 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Contact | Carl Person |
| Correspondent | Carl Person MEDIFACE CO., LTD. 2001 EAST OAKSHORES DR. Crossroads, TX 76227 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-29 |
| Decision Date | 2001-04-26 |