QUANTUM DIREX SYSTEM— 510(k) K072010
Substantially EquivalentQuantum Medical Imaging, LLC
FDA 510(k) clearance K072010 for QUANTUM DIREX SYSTEM, Substantially Equivalent on 2007-08-07. Applicant: Quantum Medical Imaging, LLC.
Clearance details
- Applicant
- Quantum Medical Imaging, LLC
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ronkonkoma, NY, 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.