TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT— 510(k) K925465

Substantially Equivalent

Life Care Imaging

FDA 510(k) clearance K925465 for TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT, Substantially Equivalent on 1993-01-27. Applicant: Life Care Imaging.

Clearance details

Applicant
Life Care Imaging
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cary, IL, 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.