LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM— 510(k) K040884

Name: FDA 510(k) clearance K040884
Creator: U.S. Food and Drug Administration
Published: 2004-04-23

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K040884 for LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2004-04-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2004-04-05
Decision date: 2004-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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