The following data is part of a premarket notification filed by Minxray, Inc. with the FDA for Impact And X-ranger.
| Device ID | K210479 |
| 510k Number | K210479 |
| Device Name: | IMPACT And X-Ranger |
| Classification | System, X-ray, Mobile |
| Applicant | MinXray, Inc. 3611 Commercial Avenue Northbrook, IL 60062 |
| Contact | Keith Kretchmer |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-19 |
| Decision Date | 2021-03-19 |