Fujifilm Healthcare Americas Corporation

Address:204 Westfield Street,Greenville,SC,29601,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Doppler, Ultrasonic (IYN) (5) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (5) System, image processing, radiological (LLZ) (5) Transducer, Ultrasonic, Diagnostic (ITX) (5)

Premarket Exempt

No Yes

Clear

Synapse Radiology PACS - 00854904006008 Catalog Number :

Device Description : Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medi Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day.

Device Class : 2

Duns Number: 041767039

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Synapse Cardiology PACS - 00854904006015 Catalog Number :

Device Description : Developed with direction from cardiologists, Synapse Cardiovascular offers capab Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.

Device Class : 2

Duns Number: 041767039

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Synapse MPR Fusion - 00854904006022 Catalog Number :

Device Description : Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MI Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use.

Device Class : 2

Duns Number: 041767039

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Synapse Mobility - 00854904006053 Catalog Number :

Device Description : Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to any authorized user, with the ability to open within applications, directly from your EHR, or on our mobile device apps.

Device Class : 2

Duns Number: 041767039

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Synapse Enterprise Viewer - 00854904006060 Catalog Number :

Device Description : Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports.

Device Class : 2

Duns Number: 041767039

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

C9150LA - 00860007188305 Catalog Number :

Device Description : 4-way Laparoscopic Ultrasound Transducer/Smart Connector

Device Class : 2

Duns Number: 603156043

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

UST 5550-R - 00860007188312 Catalog Number :

Device Description : Ultrasound Robotic Probe

Device Class : 2

Duns Number: 603156043

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

UST-9150 - 00860007188329 Catalog Number :

Device Description : Ultrasound Laparoscopic Probe

Device Class : 2

Duns Number: 603156043

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

UST-52114P-B - 00860007188336 Catalog Number :

Device Description : Ultrasound Brainpath Probe

Device Class : 2

Duns Number: 603156043

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : No

Device Count : 1

Transducer S12BP4 - 00860007188343 Catalog Number :

Device Description : Transducer S12BP4 – 11 mm Neurosurgery Probe

Device Class : 2

Duns Number: 603156043

Premarket Exempt : No

Product Code : IYO, ITX, IYN

Prescription Use : Yes

Device Count : 1

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