Synapse Cardiology PACS

GUDID 00854904006015

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.

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

Radiology picture archiving and communication system workstation

• Primary Device ID: 00854904006015
• NIH Device Record Key: 0790ffd1-2acd-4c20-8171-2652122f73b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synapse Cardiology PACS
• Version Model Number: Synapse Cardiology 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	00854904006015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151859

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: 2019-05-29 Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system th
• 00854904006015 - Synapse Cardiology PACS: 2019-05-29Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.
• 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