QCT-BONE MINERAL ANALYSIS SOFTWARE— 510(k) K941127

Substantially Equivalent

Image Analysis, Inc.

FDA 510(k) clearance K941127 for QCT-BONE MINERAL ANALYSIS SOFTWARE, Substantially Equivalent on 1995-05-11. Applicant: Image Analysis, Inc..

Clearance details

Applicant: Image Analysis, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1994-03-09
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, KY, US

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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.