The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Krystalrad New Seriesdigital Radiographic Portable Retrofit System.
| Device ID | K130377 |
| 510k Number | K130377 |
| Device Name: | KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | MEDICATECH USA 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. MEDICATECH USA 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-05-17 |
| Summary: | summary |