FLUOROSCOPIC IMAGE INTENSIFIER— 510(k) K840621

Substantially Equivalent

Phoenix Radiology, Ltd.

FDA 510(k) clearance K840621 for FLUOROSCOPIC IMAGE INTENSIFIER, Substantially Equivalent on 1984-06-05. Applicant: Phoenix Radiology, Ltd..

Clearance details

Applicant
Phoenix Radiology, Ltd.
Product code
Code JAA
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, 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.