Identifiers
- 510(k) Number
- K230913 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Andi is an automated radiological image processing software platform designed for the display and analysis of medical images. It utilizes diffusion tensor imaging combined with artificial intelligence to assist in assessing the extent of brain damage by analyzing white matter.
This clinical software is supplied by Imeka Solutions, Inc. and received FDA 510(k) clearance on July 25, 2023. It is intended for use in clinical settings for the processing and display of medical imaging data.
Frequently asked questions
What is the primary clinical function of the Andi software?
Andi is designed for the display and analysis of medical images. It specifically utilizes diffusion tensor imaging combined with artificial intelligence to assist clinicians in assessing the extent of brain damage by analyzing white matter.
Is the Andi software intended for use in clinical environments?
Yes, the software is intended for use in clinical settings for the processing and display of medical imaging data to support radiological assessment.
What is the regulatory status of the Andi platform?
The Andi software received FDA 510(k) clearance on July 25, 2023, under the k-number K230913. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Get to know ANDI™ | Imeka™, ANDI - Automated Radiological Image Processing Software, Imeka Solutions — Health AI Company Profile, ANDI by Imeka Solutions, Inc. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230913 | Class II | Active |
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Manufacturer
- Manufacturer
- Imeka Solutions, Inc.
Sources (1)
- FDA 510(k) K230913 24 fields · synced Sep 26, 2026