The following data is part of a premarket notification filed by Pixmeo Sarl with the FDA for Osirix Md.
| Device ID | K101342 |
| 510k Number | K101342 |
| Device Name: | OSIRIX MD |
| Classification | System, Image Processing, Radiological |
| Applicant | PIXMEO SARL 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-13 |
| Decision Date | 2010-08-20 |
| Summary: | summary |