The following data is part of a premarket notification filed by Calgary Scientific, Inc. with the FDA for Resolutionmd Mobile Model Rmb-mob-2x.
| Device ID | K111346 |
| 510k Number | K111346 |
| Device Name: | RESOLUTIONMD MOBILE MODEL RMB-MOB-2X |
| Classification | System, Image Processing, Radiological |
| Applicant | CALGARY SCIENTIFIC, INC. SUITE 208, 1210 20TH AVENUE SE Calgary, Alberta, CA T2g 1m8 |
| Contact | Kyle Peterson |
| Correspondent | Kyle Peterson CALGARY SCIENTIFIC, INC. SUITE 208, 1210 20TH AVENUE SE Calgary, Alberta, CA T2g 1m8 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-13 |
| Decision Date | 2011-09-09 |