QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE— 510(k) K894854

Substantially Equivalent

Image Enhancements

FDA 510(k) clearance K894854 for QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE, Substantially Equivalent on 1989-10-19. Applicant: Image Enhancements.

Clearance details

Applicant: Image Enhancements
Product code: Code KGI
Advisory panel: Radiology
Date received: 1989-07-31
Decision date: 1989-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.