OpenSight

GUDID B109OPENSIGHT187060

OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT.

NOVARAD CORPORATION

Radiological PACS software

• Primary Device ID: B109OPENSIGHT187060
• NIH Device Record Key: 9ea39d1f-1f18-4958-95ba-5565571f2233
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OpenSight
• Version Model Number: OpenSight 1.8706
• Company DUNS: 071991843
• Company Name: NOVARAD 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net
• Phone: 18776682723
• Email: info@novarad.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B109OPENSIGHT187060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172418

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: 2
• Public Version Date: 2023-10-18
• Device Publish Date: 2019-08-16

On-Brand Devices [OpenSight]

• B109OPENSIGHT180760: OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software
• B109OPENSIGHT188040: OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software
• B109OPENSIGHT187060: OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software