OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W— 510(k) K992775

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K992775 for OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Substantially Equivalent on 1999-10-01. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1999-08-18
Decision date: 1999-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, 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.