Cleared Special

Biopsy Positioner

K191495 · Fujifilm Corporation · Radiology
Jul 2019
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K191495 is an FDA 510(k) clearance for the Biopsy Positioner, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Fujifilm Corporation (Ashigarakami-Gun, JP). The FDA issued a Cleared decision on July 3, 2019, 28 days after receiving the submission on June 5, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K191495 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710