Cleared Traditional

BIOPSY POSITIONER (K113284) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113284 · Fuji Film Medical Systems · Radiology device
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Mar 2012
Decision
121d
Days
Class 2
Risk

K113284 is an FDA 510(k) clearance for the BIOPSY POSITIONER. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Fuji Film Medical Systems (Stamford, US). The FDA issued a Cleared decision on March 7, 2012 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fuji Film Medical Systems devices

Submission Details

510(k) Number K113284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2011
Decision Date March 07, 2012
Days to Decision 121 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 107d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 16
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K113284.
SMART FINDER
K203509 · Ims Giotto S.P.A. · Jul 2021
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
OPDIMA
K003945 · Siemens Medical Solutions USA, Inc. · Feb 2001
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · Siemens Medical Solutions USA, Inc. · May 1997
PREFERENCE MAMMOGRAPHY SYSTEM
K945743 · Philips Medical Systems (Cleveland), Inc. · Mar 1995