Synapse Pathology

GUDID 00854904006039

Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.

Fujifilm Healthcare Americas Corporation

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

• Primary Device ID: 00854904006039
• NIH Device Record Key: 995a9a1d-5eb8-4173-86b6-ad78e3e7ee80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synapse Pathology
• Version Model Number: Synapse Pathology Software License
• Company DUNS: 041767039
• Company Name: Fujifilm Healthcare Americas Corporation
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854904006039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210811

FDA Product Code

• QKQ: Digital Pathology Image Viewing And Management Software

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-26
• Device Publish Date: 2023-06-16

Devices Manufactured by Fujifilm Healthcare Americas Corporation

• 00854904006039 - Synapse Pathology: 2023-06-26Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.
• 00854904006039 - Synapse Pathology: 2023-06-26 Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating
• 00860007188343 - Transducer S12BP4: 2022-06-16 Transducer S12BP4 – 11 mm Neurosurgery Probe