IMAGECHECKER CT CAD SOFTWARE SYSTEM— 510(k) K043617

Name: FDA 510(k) clearance K043617
Creator: U.S. Food and Drug Administration
Published: 2007-12-21

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K043617 for IMAGECHECKER CT CAD SOFTWARE SYSTEM, Substantially Equivalent on 2007-12-21. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code OEB
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-11-26
Decision date: 2007-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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