BIOPSY POSITIONER— 510(k) K113284

Substantially Equivalent

Fuji Film Medical Systems

FDA 510(k) clearance K113284 for BIOPSY POSITIONER, Substantially Equivalent on 2012-03-07. Applicant: Fuji Film Medical Systems. Device class: 2.

Clearance details

Applicant: Fuji Film Medical Systems
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2011-11-07
Decision date: 2012-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stamford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZH

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K191495 — Biopsy Positioner2019-07-03
K161575 — Affirm Lateral Arm Upright Biopsy Accessory2016-08-10
K161920 — Comfort Cover2016-07-15

Recalls naming K113284

K-number listed on FDA's recall record

Z-2690-2016 — FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.Class II·Terminated·Fujifilm Medical Systems U.S.A., Inc.·20160609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113284.

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