DTX-100— 510(k) K926300

Name: FDA 510(k) clearance K926300
Creator: U.S. Food and Drug Administration
Published: 1993-07-23

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K926300 for DTX-100, Substantially Equivalent on 1993-07-23. 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: 1992-12-14
Decision date: 1993-07-23
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.