QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA)— 510(k) K993763
Substantially EquivalentMedis Medical Imaging Systems BV
FDA 510(k) clearance K993763 for QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA), Substantially Equivalent on 1999-11-26. Applicant: Medis Medical Imaging Systems BV.
Clearance details
- Applicant
- Medis Medical Imaging Systems BV
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ridgefield, CT, US
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.