FUJIFILM Healthcare Americas Corporation

FDA Device Registration & Listing · Twinsburg, OH, US · Registration 1528028

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
1528028
FEI Number
1528028
Entity Name
FUJIFILM Healthcare Americas Corporation
City/State/Country
Twinsburg, OH, US
Establishment Address
1959 Summit Commerce Park, Twinsburg, OH 44087, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
FUJIFILM Healthcare Americas Corporation (Owner Number: 10082284)
Owner / Operator Contact Address
81 Hartwell Avenue, Suite 100, Lexington, MA 02421, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

C9150LA S12BP4 Neurosurgery Probe UST-9150

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-07-10
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-07-10
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-07-10
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-05-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-05-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-05-31

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
3008491142 FUJIFILM Healthcare Americas Corporation Lexington, MA, 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-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1528028. Last updated year: 2026. Please use registration number 1528028 when referencing this establishment in official correspondence.
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