AccipioIx - AccipioIx is a software workflow tool designed to - MAXQ AI LTD

Duns Number:600570388

Device Description: AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessm 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.

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More Product Details

Catalog Number

-

Brand Name

AccipioIx

Version/Model Number

V2.3 and subsequent minor V2.x releases

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K201310

Product Code Details

Product Code

QAS

Product Code Name

Radiological Computer-Assisted Triage And Notification Software

Device Record Status

Public Device Record Key

623fb3f0-9b89-4c55-8900-3532ff2260e8

Public Version Date

September 22, 2021

Public Version Number

1

DI Record Publish Date

September 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXQ AI LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2