CAMTEX 1000— 510(k) K840134

Substantially Equivalent

Digital Imaging Co. of America

FDA 510(k) clearance K840134 for CAMTEX 1000, Substantially Equivalent on 1984-03-16. Applicant: Digital Imaging Co. of America.

Clearance details

Applicant
Digital Imaging Co. of America
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JAA

product code JAA
Other
1
Total
1

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.