FUJIFILM Healthcare Americas Corporation

FDA Device Registration & Listing · Lexington, MA, US · Registration 3008491142

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
3008491142
FEI Number
3008491142
Entity Name
FUJIFILM Healthcare Americas Corporation
City/State/Country
Lexington, MA, US
Establishment Address
81 Hartwell Ave Ste 100, Lexington, MA 02421, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
FUJIFILM Healthcare Americas Corporation (Owner Number: 10043450)
Owner / Operator Contact Address
81 Hartwell Avenue, Suite 100, Lexington, MA 02421, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210811
PMA Number
N/A

All Registered Proprietary Names

Synapse Pathology Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PSY Whole Slide Imaging System Pathology Class 2 864.3700 2022-06-01
QKQ Digital Pathology Image Viewing And Management Software Pathology Class 2 864.3700 2022-06-01

Official Correspondent

Randy Vader

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUJIFILM Healthcare Americas 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
1528028 FUJIFILM Healthcare Americas Corporation Twinsburg, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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 3008491142. Last updated year: 2026. Please use registration number 3008491142 when referencing this establishment in official correspondence.
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