DEMASQ IMAGING SPFTWARE DEVICE— 510(k) K090481

Substantially Equivalent

Demasq Limited

FDA 510(k) clearance K090481 for DEMASQ IMAGING SPFTWARE DEVICE, Substantially Equivalent on 2009-03-19. Applicant: Demasq Limited.

Clearance details

Applicant
Demasq Limited
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cardiff Wales, GB
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.