RemotEye Viewer

GUDID B383REV090102000

Diagnostic web DICOM viewer

NEOLOGICA SRL

Radiology picture archiving and communication system application software Radiology picture archiving and communication system application software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: B383REV090102000
• NIH Device Record Key: 1088699d-4829-4d35-910c-8504175fe1af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RemotEye Viewer
• Version Model Number: 9.1.2
• Company DUNS: 517480120
• Company Name: NEOLOGICA SRL
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it
• Phone: +39019505314
• Email: info@neologica.it

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B383REV090102000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141061

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: 2018-09-24
• Device Publish Date: 2016-09-23

On-Brand Devices [RemotEye Viewer]

• B383REV090203000: Diagnostic web DICOM viewer
• B383REV090202000: Diagnostic web DICOM viewer
• B383REV090201000: Diagnostic web DICOM viewer
• B383REV090200000: Diagnostic web DICOM viewer
• B383REV090102000: Diagnostic web DICOM viewer
• B383REV100001000: Diagnostic web DICOM viewer
• B383REV100000000: Diagnostic web DICOM viewer
• B383REV090204000: Diagnostic web DICOM viewer
• B383REV100002000: Diagnostic web DICOM viewer