FUJIFILM Healthcare Americas Corporation

• FDA — Gastroenterology, Urology2 devices
• JAK — Radiology2 devices
• LNH — Radiology2 devices
• QIH — Radiology2 devices
• EOQ — Ear, Nose, Throat1 device
• FDS — Gastroenterology, Urology1 device
• FED — Gastroenterology, Urology1 device
• ITX — Radiology1 device
• IYN — Radiology1 device

• Z-3030-2026 — FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemClass II·Ongoing·2026-07-22
• Z-1299-2026 — FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)Class II·Ongoing·2026-01-09
• Z-0044-2026 — FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33Class II·Ongoing·2025-09-15
• Z-2219-2025 — ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).Class II·Ongoing·2025-06-11
• Z-1407-2025 — Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.Class II·Ongoing·2025-02-11
• Z-1898-2024 — FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33Class II·Ongoing·2024-04-11
• Z-1884-2024 — Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24Class II·Ongoing·2024-04-11
• Z-1271-2024 — Synapse PACS - Version 7.2.100Class II·Ongoing·2024-01-10
• Z-1269-2024 — Synapse PACS - Version 7.1.000USClass II·Ongoing·2024-01-10
• Z-1272-2024 — Synapse PACS - Version 7.2.200Class II·Ongoing·2024-01-10

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K261713 — Synapse PACS (7.6.0)Code QIH·2026-06-18
• K251204 — FUJIFILM Stiffening Wire Device (SW-2000)Code FDA·2025-09-26
• K243647 — Synapse PACS (7.5)Code QIH·2025-06-30
• K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214CCode FDA·2024-06-13
• K233629 — APERTO Lucent MRI SystemCode LNH·2024-05-10
• K233687 — ECHELON Synergy V10.0Code LNH·2024-05-03
• K233583 — FCT iSTREAM Phase 1Code JAK·2024-04-26
• K240075 — FUJIFILM Endoscope Model EB-710XTCode EOQ·2024-02-07
• K231666 — Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)Code ITX·2023-12-13
• K231941 — ARIETTA x10Code IYN·2023-11-20
• K231574 — Scenaria View 4.2Code JAK·2023-10-12
• K230752 — Over-tube (3 models)Code FED·2023-09-15
• K232314 — Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)Code FDS·2023-09-01