Cleared Special

K191495 - Biopsy Positioner

K191495 is the FDA 510(k) clearance for Biopsy Positioner by Fujifilm Corporation. It is a Class 2 Radiology device (product code IZH) cleared through the Special 510(k) pathway after a 28-day FDA review.

K191495 · Fujifilm Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
28d
Days
Class 2
Risk

K191495 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 Fujifilm Corporation (Ashigarakami-Gun, JP). The FDA issued a Cleared decision on July 3, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Corporation devices

Submission Details

510(k) Number K191495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2019
Decision Date July 03, 2019
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Fujifilm Medical Systems U.S.A, Inc.
Jeffrey Wan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZH System, X-ray, Mammographic

All 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K191495.
SMART FINDER
K203509 · Ims Giotto S.P.A. · Jul 2021
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Affirm Prone Biopsy System
K153486 · Hologic, Inc. · Apr 2016
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · Hologic, Inc. · Jan 2011
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 2004