The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Minxray Model Cmdr-2s.
| Device ID | K100449 |
| 510k Number | K100449 |
| Device Name: | MINXRAY MODEL CMDR-2S |
| Classification | System, X-ray, Mobile |
| Applicant | MINXRAY, INC. 8726 FERRARA CT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. MINXRAY, INC. 8726 FERRARA CT Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-04-23 |
| Summary: | summary |