The following data is part of a premarket notification filed by Summit Industries Llc with the FDA for Amrad Medical Aau Digital Radiography System; Amrad Medical Aau Plus Digital Radiography System; Amrad Medical Dfmt Digital Radiography System; Amrad Medical Fmt Digital Radiography System.
| Device ID | K173823 |
| 510k Number | K173823 |
| Device Name: | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System |
| Classification | System, X-ray, Stationary |
| Applicant | Summit Industries LLC 2901 W Lawrence Ave Chicago, IL 60625 |
| Contact | Tom Boon |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-02-09 |
| Summary: | summary |