MODIFIED M-IV MAMMOGRAPHY SYSTEM— 510(k) K011987

Name: FDA 510(k) clearance K011987
Creator: U.S. Food and Drug Administration
Published: 2001-07-11

Substantially Equivalent

Lorad, A Hologic Co.

FDA 510(k) clearance K011987 for MODIFIED M-IV MAMMOGRAPHY SYSTEM, Substantially Equivalent on 2001-07-11. 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: 2001-06-26
Decision date: 2001-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Danbury, CT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K011987

K-number listed on FDA's recall record

Z-1701-2014 — Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.Class II·Terminated·Hologic, Inc.·20140513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011987.

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