HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1— 510(k) K871446

Name: FDA 510(k) clearance K871446
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K871446 for HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1, Substantially Equivalent on 1987-10-20. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 1987-04-13
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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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.