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 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: 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