The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Krystalrad 11000 And Krystalrad 3000 Digital Stationary Radiographic System.
| Device ID | K143257 |
| 510k Number | K143257 |
| Device Name: | KrystalRad 11000 And KrystalRad 3000 Digital Stationary Radiographic System |
| Classification | System, X-ray, Stationary |
| Applicant | MEDICATECH USA 50 MAXWELL Irvine, CA 92618 |
| Contact | George Makar |
| Correspondent | Daniel Kamm, P.e. 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 | 2014-11-13 |
| Decision Date | 2015-02-06 |
| Summary: | summary |