The following data is part of a premarket notification filed by Summit Industries Llc with the FDA for Amrad Medical Ots Digital Radiography System, Amrad Medical Dfmts Digital Radiography Systemamrad Medical Frs Digital Radiography System,.
| Device ID | K153119 |
| 510k Number | K153119 |
| Device Name: | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS 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 | 2015-10-29 |
| Decision Date | 2016-03-14 |
| Summary: | summary |