The following data is part of a premarket notification filed by Clario Medical Imaging, Inc. with the FDA for Mediq Version 1.0.
| Device ID | K052963 |
| 510k Number | K052963 |
| Device Name: | MEDIQ VERSION 1.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | CLARIO MEDICAL IMAGING, INC. 725 NORTH STATE STREET Bellingham, WA 98225 |
| Contact | Patricia A Milbank |
| Correspondent | Patricia A Milbank CLARIO MEDICAL IMAGING, INC. 725 NORTH STATE STREET Bellingham, WA 98225 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-21 |
| Decision Date | 2005-12-05 |
| Summary: | summary |