Synapse Radiology PACS

GUDID 00854904006008

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.

FUJIFILM MEDICAL SYSTEMS U.S.A., INC.

Radiology picture archiving and communication system workstation

• Primary Device ID: 00854904006008
• NIH Device Record Key: 3a241222-12cd-40d7-b2d0-ab4a6845393c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synapse Radiology PACS
• Version Model Number: Synapse Radiology PACS Software License
• Company DUNS: 041767039
• Company Name: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx
• Phone: +018002728465
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854904006008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160108

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-29
• Device Publish Date: 2016-09-23

Devices Manufactured by FUJIFILM MEDICAL SYSTEMS U.S.A., INC.

• 00854904006060 - Synapse Enterprise Viewer: 2019-05-31 Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated readi
• 00854904006008 - Synapse Radiology PACS: 2019-05-29Synapse, 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.
• 00854904006008 - Synapse Radiology PACS: 2019-05-29 Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system th
• 00854904006015 - Synapse Cardiology PACS: 2019-05-29 Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow,
• 00854904006022 - Synapse MPR Fusion: 2019-05-29 Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical
• 00854904006053 - Synapse Mobility: 2019-05-29 Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side