AccipioIx

GUDID 00860001219531

AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.

MAXQ AI LTD

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• Primary Device ID: 00860001219531
• NIH Device Record Key: 623fb3f0-9b89-4c55-8900-3532ff2260e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccipioIx
• Version Model Number: V2.3 and subsequent minor V2.x releases
• Company DUNS: 600570388
• Company Name: MAXQ AI LTD
• 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: true
• 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: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai
• Phone: +1-617-765-0333
• Email: support@maxq.ai

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001219531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201310

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: 2021-09-22
• Device Publish Date: 2021-09-14

On-Brand Devices [AccipioIx]

• 00860001219500: AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of
• 00860001219531: AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of