HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER— 510(k) K913321

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K913321 for HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER, Substantially Equivalent on 1991-11-01. Applicant: Hologic, Inc..

Clearance details

Applicant: Hologic, Inc.
Product code: Code KGI
Advisory panel: Radiology
Date received: 1991-07-25
Decision date: 1991-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, 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.