MODIFIED 650 MAMMOGRAPHY SYSTEM— 510(k) K013290

Name: FDA 510(k) clearance K013290
Creator: U.S. Food and Drug Administration
Published: 2001-10-24

Substantially Equivalent

Lorad, A Hologic Co.

FDA 510(k) clearance K013290 for MODIFIED 650 MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2001-10-24. Applicant: Lorad, A Hologic Co.. Device class: 2.

Clearance details

Applicant: Lorad, A Hologic Co.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2001-10-02
Decision date: 2001-10-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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