RemotEye Viewer

GUDID B383REV100100000

Diagnostic web DICOM viewer

NEOLOGICA SRL

Radiological PACS software

• Primary Device ID: B383REV100100000
• NIH Device Record Key: 9f807ccd-4971-4931-ab04-cfd4d9e70573
• Commercial Distribution Discontinuation: 2025-08-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RemotEye Viewer
• Version Model Number: 10.1.0
• 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: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it
• Phone: +39019505314
• Email: support@neologica.it

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B383REV100100000 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-19
• Device Publish Date: 2025-08-11

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
• B383REV100200000: Diagnostic web DICOM viewer
• B383REV100100000: Diagnostic web DICOM viewer