Fujifilm Corporation (manufacturer, ASHIGARAKAMI-GUN Kanagawa, JP): 14 new FDA device listings, incl. gastrointesinal lesion software detection system

Fujifilm Corporation (ASHIGARAKAMI-GUN Kanagawa): 14 new FDA device listings, incl. gastrointesinal lesion software detection system. Its amount of 14 is top-decile (95th percentile of 2,709 records). Dated 69 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 14 · 95th percentile of 2,709 DeviceEstablishmentPulse records · 7.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 60 related JP DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentFujifilm Corporation
RoleManufacturer
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
LocationASHIGARAKAMI-GUN Kanagawa, JP
New listings14
DevicesGastrointesinal Lesion Software Detection System; System, Image Processing, Radiological; Automated Radiological Image Processing Software; Lung Computed Tomography System, Computer-Aided Detection; Led Light Source; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Endoscopic Light-Projecting Measuring Device; Endoscope, Accessories, Image Post-Processing For Color Enhancement; Colonoscope And Accessories, Flexible/Rigid; Enteroscope And Accessories
Product codesQNP, LLZ, QIH, OEB, NTN, FET, QTH, PEA, FDF, FDA, NWB, IYN, ITX, IYO
Device classesClass II
Medical specialtiesGastroenterology, Urology, Radiology
Brand namesEW10-EC02; Synapse 3D Base Tools (V7.2); Synapse Lung Nodule AI; EP-8000; EW10-VM01; PB-30; L15-5 Transducer; Sonosite iLOOK Ultrasound System
First new listing2026-05-08
Latest new listing2026-08-28
FDA registration number3001722928
Registration expires2026-12-31
amount percentile95th of 2,709 (median 2, 7.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-08-28
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Fujifilm Corporation and 61 JP peers

  • JP DeviceEstablishmentPulse records like this one: 61
  • Fujifilm Corporation's amount: 95th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every JP peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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75 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • Several new listings at once.

What is the DeviceEstablishmentPulse record for Fujifilm Corporation in ASHIGARAKAMI-GUN Kanagawa?

Fujifilm Corporation (ASHIGARAKAMI-GUN Kanagawa, JP), a manufacturer, added 14 FDA device listings between 2026-05-08 and 2026-08-28.

How does Fujifilm Corporation compare to other DeviceEstablishmentPulse records?

This is a top-decile record: its amount of 14 is 7.0x the median of 2 across 2,709 records. It is 69 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.

Fujifilm Corporation vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Fujifilm CorporationASHIGARAKAMI-GUN Kanagawa, JP1495th2026-08-28
Coopersurgical, Inc.Trumbull, CT1495th2026-10-20
Intuitive Surgical, Inc.Sunnyvale, CA1395th2026-10-22
Intuitive Surgical, Inc.Santa Clara, CA1395th2026-10-22

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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