Identity
- Trade Name
- AccipioIx FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- V1.6 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- ACC-IX0 V1.6 and V2.2 FDA UDI
- Primary DI / UDI-DI
- 00860001219500 FDA UDI
- 510(k) Number
- K182177 FDA UDI
- FDA Product Code
- QAS FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiology DICOM image processing application software
AccipioIx by Maxq Ai Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiology DICOM image processing application software.
- Imbio Freya — Imbio, LLC · Class II
- Pacs View — BRIT SYSTEMS · Class II
- XR90 System, LOGIQ, Upgrade Kit — MediView XR · Class II
- OptiVu™ Mixed Reality — Orthosoft Inc · Class II
- PowerLook PRO+ Rack-Mount, OUS — Icad, Inc. · Class I
- Annalise Triage — Annalise-Ai Pty , Ltd. · Class II
- PowerLook PRO+ 4GPU Tower Platform, US — Icad, Inc. · Class I
- PowerLook PRO+ 4GPU Tower Platform, OUS — Icad, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maxq Ai Ltd
Sources (1)
- FDA UDI 8430c6ff-95cf-498e-abe6-9ff7fd2542c7 36 fields · synced Jun 1, 2026