Biopsy Positioner— 510(k) K191495

Substantially Equivalent

Fujifilm Corporation

FDA 510(k) clearance K191495 for Biopsy Positioner, Substantially Equivalent on 2019-07-03. Applicant: Fujifilm Corporation. Device class: 2.

Clearance details

Applicant: Fujifilm Corporation
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2019-06-05
Decision date: 2019-07-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashigarakami-Gun, JP

Download summary PDF View on FDA.gov ↗

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