DIGITAL SPOT MAMMOGRAPHY SYSTEM— 510(k) K100692

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K100692 for DIGITAL SPOT MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2010-04-06. 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: 2010-03-10
Decision date: 2010-04-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.