510(k) Report

FDA applicant

Fujifilm Corporation

Ashigara Kami-Gun, JP71 decisions2018–202611 recalls

FDA records 71 decisions for Fujifilm Corporation (Ashigara Kami-Gun, JP) from 2018 to 2026: 71 510(k) clearances. Most are in product codes FDS (Gastroscope And Accessories, Flexible/Rigid) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 93 predicates, 34 of them its own earlier devices. 11 recalls are linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Fujifilm Corporation’s devices, and how often a recall has named them.

FDA decisions per year

8in 2025

2018: 72019: 202020: 62021: 52022: 62023: 22024: 32025: 82026 (partial year): 14
2018high 20 (2019) · low 2 (2023)2026

2026 so far, outlined.

Recalls per year

1in 2026

2020: 22024: 72025: 12026 (partial year): 1
2018high 7 (2024) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Fujifilm Corporation by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • FDSGastroscope And Accessories, Flexible/Rigid15decisions
  • LLZSystem, Image Processing, Radiological6decisions
  • EOQBronchoscope (Flexible Or Rigid)6decisions
  • FDTDuodenoscope And Accessories, Flexible/Rigid5decisions
  • FDFColonoscope And Accessories, Flexible/Rigid5decisions
  • ODGEndoscopic Ultrasound System, Gastroenterology-Urology4decisions

Also: LNH (4), FDA (3), MQB (3), FET (3), JAK (3), QNP (2).

How long do its 510(k) reviews take?

Since 2016, its 61 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 130 days; 27 of its 61 were faster than that.

Whose devices does it build on?

Its devices cite 93 predicates; 34 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 52 times; 34 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.

  • K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603Fujifilm Corporation · 201811cite it
  • K210162Endoscope Model EI-740D/SFujifilm Corporation · 20213cite it
  • K192918Video Laparoscope, Video Processor, Light SourceFujifilm Corporation · 20202cite it
  • K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation · 20192cite it
  • K183607FUJIFILM BronchoscopeFujifilm Corporation · 20192cite it
  • K221677Synapse 3D Base Tools v6.6Fujifilm Corporation · 20222cite it

What has FDA decided for it lately?

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026
  • K261170BA-004CCFujifilm Corporation · 2026
  • K260567EW10-EC02 Endoscopy Support ProgramFujifilm Corporation · 2026
  • K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm Corporation · 2026
  • K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026

All 71 as Fujifilm Corporation →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K190232FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemJul 22, 2026Class II
  • K160108Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010…Feb 11, 2025Class II
  • K190232Synapse PACS - Version 7.2.200Jan 10, 2024Class II
  • K190232Synapse PACS - Version 7.2.100Jan 10, 2024Class II
  • K190232Synapse PACS - Version 7.1.000Jan 10, 2024Class II
  • K190232Synapse PACS - Version 7.2.000Jan 10, 2024Class II

Other applicant names beginning “Fujifilm”

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

Fujifilm Medical System U.S.A., Inc. 72Fujifilm Medical Systems U.S.A, Inc. 40FUJIFILM Sonosite, Inc. 25FUJIFILM Healthcare Americas Corporation 13Fujifilm Healthcare Corporation 6Fujifilm Corporaton 6Fujifilm Irvine Scientific 5Fujifilm New Development U.S.A., Inc. 3Fujifilm Medwork GmbH 2Fujifilm Meidcal Systems U.S.A.,Inc. 2