HORIZON MEDICAL IMAGING— 510(k) K043146

Substantially Equivalent

Mckesson Medical Imaging Company

FDA 510(k) clearance K043146 for HORIZON MEDICAL IMAGING, Substantially Equivalent on 2005-01-04. Applicant: Mckesson Medical Imaging Company.

Clearance details

Applicant
Mckesson Medical Imaging Company
Product code
Code LLZ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Richmond, B.C., CA
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.