KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System— 510(k) K143257
Substantially EquivalentMedicatech USA
FDA 510(k) clearance K143257 for KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System, Substantially Equivalent on 2015-02-06. Applicant: Medicatech USA.
Clearance details
- Applicant
- Medicatech USA
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.