Aspire Hd Plus, Aspire Hd-S

• • Terminated Z-0660-2018 FDA Class II ·initiated 4 Aug 2017

  FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.

• • Terminated Z-0385-2018 FDA Class II ·initiated 14 Jul 2017

  There was a case that the swivel arm went down unintentionally when it was moved up/down.

510(k) Number

K121674 ↗

FDA Product Code

MUE

Device Class

Class II

Regulation

21 CFR Part 892.1715

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Fdr Acselerate System, Dr-Id 200 Flat Panel Detector

  Class II

  FDA 510(k) K093427 Active Cleared 21 Jan 2010

• Fuji Medical CR Console Flash IIP

  Class II

  FDA 510(k) K041990 Active Cleared 6 Aug 2004

• Fuji Computed Radiography (Fcr) Clearview Cs Image Reader

  Class II

  FDA 510(k) K042023 Active Cleared 25 Aug 2004

• Fuji Speed Suite, Fuji Speed Sute Phase II

  Class II

  FDA 510(k) K013218 Active Cleared 20 Dec 2001

• ASPIRE Bellus II

  Class II

  FDA 510(k) K171463 Active Cleared 29 Sep 2017

• Synapse 3D Nodule Analysis

  Class II

  FDA 510(k) K120679 Active Cleared 1 Jun 2012

See all devices from Fujifilm Medical System U.S.A., Inc. →