MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE— 510(k) K900586

Substantially Equivalent

Medrad, Inc.

FDA 510(k) clearance K900586 for MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE, Substantially Equivalent on 1990-02-23. Applicant: Medrad, Inc..

Clearance details

Applicant
Medrad, Inc.
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pittsburgh, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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.