FUJIFILM Healthcare Americas Corporation

FDA Device Registration & Listing · Durham, NC, US · Registration 3004972322

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004972322
FEI Number
3004972322
Entity Name
FUJIFILM Healthcare Americas Corporation
City/State/Country
Durham, NC, US
Establishment Address
79 TW Alexander Drive, Building 4501, Durham, NC 27709, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FUJIFILM CORPORATION (Owner Number: 8031568)
Owner / Operator Contact Address
26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K243647
PMA Number
N/A

All Registered Proprietary Names

Synapse PACS 7.X Synapse PACS Synapse Enterprise Viewer Synapse CardioVascular Synapse PACS Synapse PACS 5.X Synapse PACS Synapse PACS 7.5

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-03-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-05-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-04-07
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2016-03-28
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-07-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUJIFILM CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3020707080 FUJIFILM medwork GmbH Hochstadt/Aisch Bavaria, DE
3008787461 FUJIFILM Imaging System (Suzhou) Co., Ltd. Suzhou Jiangsu, CN
2155 FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office MINAMIASHIGARA-SHI Kanagawa, JP
3005625991 FUJIFILM Healthcare Americas Corporation Edison, NJ, US
3034364687 FUJIFILM Corporation Material Manufacturing Headquarters Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K233629 FUJIFILM Healthcare Americas Corporation APERTO Lucent MRI System 2024-05-10
K233687 FUJIFILM Healthcare Americas Corporation ECHELON Synergy V10.0 2024-05-03
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0044-2026 FUJIFILM Healthcare Americas Corporation 2
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
Z-1171-2024 FUJIFILM Healthcare Americas Corporation 2
Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.
Z-1172-2024 FUJIFILM Healthcare Americas Corporation 2
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
Z-1268-2024 FUJIFILM Healthcare Americas Corporation 2
Synapse PACS - Version 7.1.000
Z-1269-2024 FUJIFILM Healthcare Americas Corporation 2
Synapse PACS - Version 7.1.000US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004972322. Last updated year: 2026. Please use registration number 3004972322 when referencing this establishment in official correspondence.
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