IMIX DIGITAL THORAX SYSTEM— 510(k) K974863

Substantially Equivalent

Advanced Instrument Development, Inc.

FDA 510(k) clearance K974863 for IMIX DIGITAL THORAX SYSTEM, Substantially Equivalent on 1998-03-17. Applicant: Advanced Instrument Development, Inc..

Clearance details

Applicant
Advanced Instrument Development, Inc.
Product code
Code KPR
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Melrose Park, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KPR

product code KPR
Other
6
Total
6

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.