510(k) Report

FDA applicant

Fuji Film Medical Systems

Stamford, CT1 decision2012–20121 recall

FDA records 1 decision for Fuji Film Medical Systems (Stamford, CT) in 2012: 1 510(k) clearance. All are in product code IZH (System, X-Ray, Mammographic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Fuji Film Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2012high 1 (2016) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Fuji Film Medical Systems by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fuji Film Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IZHSystem, X-Ray, Mammographic1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113284Biopsy PositionerFuji Film Medical Systems · 20121cites it

What has FDA decided for it lately?

  • K113284Biopsy PositionerFuji Film Medical Systems · 20121 recall

The one decision as Fuji Film Medical Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K110729FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner…Jun 9, 2016Class II

Other applicant names beginning “Fuji”

FDA records each applicant name separately; these may or may not be the same firm.

Fuji Dynamics Limited 12Fuji Systems Corp. 3Fuji Optical Systems, Inc. 1