The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Cmdr 2st (multiple Models), Cmdr 2spe (multiple Models), Integris.
| Device ID | K171353 |
| 510k Number | K171353 |
| Device Name: | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris |
| Classification | System, X-ray, Mobile |
| Applicant | MinXray, Inc. 3611 Commercial Ave Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858846007222 | K171353 | 000 |
| 00858846007079 | K171353 | 000 |
| 00858846007086 | K171353 | 000 |
| 00858846007093 | K171353 | 000 |
| 00858846007109 | K171353 | 000 |
| 00858846007116 | K171353 | 000 |
| 00858846007123 | K171353 | 000 |
| 00858846007130 | K171353 | 000 |
| 00858846007147 | K171353 | 000 |
| 00858846007154 | K171353 | 000 |
| 00858846007161 | K171353 | 000 |
| 00858846007178 | K171353 | 000 |
| 00858846007185 | K171353 | 000 |
| 00858846007192 | K171353 | 000 |
| 00858846007208 | K171353 | 000 |
| 00858846007215 | K171353 | 000 |
| 00858846007062 | K171353 | 000 |