QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)— 510(k) K993765
Substantially EquivalentMedis Medical Imaging Systems BV
FDA 510(k) clearance K993765 for QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV), 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.