The following data is part of a premarket notification filed by Medicatech Usa with the FDA for Krystalrad (atal8).
| Device ID | K102285 |
| 510k Number | K102285 |
| Device Name: | KRYSTALRAD (ATAL8) |
| Classification | System, X-ray, Stationary |
| Applicant | MEDICATECH USA 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | John Ross |
| Correspondent | John Ross MEDICATECH USA 8870 RAVELLO COURT 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 | 2010-08-12 |
| Decision Date | 2011-01-03 |
| Summary: | summary |