StrokeSENS

GUDID B926SSSX10

StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.

Circle Neurovascular Imaging Inc

CT system application software

• Primary Device ID: B926SSSX10
• NIH Device Record Key: 53482d8b-5336-4b20-8b7b-48b1c888e3ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrokeSENS
• Version Model Number: v1.x
• Company DUNS: 204127042
• Company Name: Circle Neurovascular Imaging Inc
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B926SSSX10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212261

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification 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: 2022-09-07
• Device Publish Date: 2022-08-30