Identifiers
- 510(k) Number
- K192437 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)
The Arterys MICA is a cloud-based medical imaging analysis platform designed for radiologists and clinicians. It leverages artificial intelligence to process and analyze complex medical images from modalities such as CT and MRI, enhancing diagnostic capabilities with automated analytics and visualization tools.
Supplied as a web-based software solution, Arterys MICA is intended for use in clinical settings where radiologists and imaging specialists review diagnostic images. The platform is not a single-use or reusable physical device but a software application requiring internet connectivity and cloud infrastructure. It holds FDA 510(k) clearance under the product code QIH, with no explicit mention of sterility, MRI safety, or physical size specifications in the provided data.
Frequently asked questions
What types of medical images can the Arterys MICA platform analyze, and how does it enhance diagnostic capabilities?
The Arterys MICA platform is designed to process and analyze complex medical images from CT and MRI modalities. It enhances diagnostic capabilities by leveraging artificial intelligence to provide automated analytics and advanced visualization tools, helping radiologists and clinicians interpret imaging data more efficiently and accurately.
Is the Arterys MICA a physical device, or is it a software solution? How is it accessed?
The Arterys MICA is not a physical device—it is a cloud-based software platform supplied exclusively as a web-based solution. It requires internet connectivity and cloud infrastructure to function, meaning it is accessed via a compatible device (e.g., computer or tablet) with an active internet connection.
How is the Arterys MICA regulated, and what does its FDA clearance cover?
The Arterys MICA holds FDA 510(k) clearance under product code QIH, classified under the Radiology advisory committee. This clearance indicates it is deemed substantially equivalent to a predicate device, but it does not involve physical sterility, MRI safety, or physical size specifications—since it is purely a software-based diagnostic tool rather than a hardware device.
Can the Arterys MICA be used in any clinical setting, or are there specific requirements?
The platform is intended for clinical settings where radiologists and imaging specialists review diagnostic images. While it does not require physical installation, it relies on cloud infrastructure and internet connectivity, meaning it must be used in environments with stable network access and appropriate IT support for healthcare data.
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: Arterys MICA Review: Pricing, FDA Status & Alternatives | Physician AI ..., Arterys Receives FDA clearance for Arterys MICA, its web-based medical ..., K203744 FDA 510(k) - Arterys MICA | Arterys, Inc., ARTERYS: Products, FDA Status & Funding | Physician AI Tools
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192437 | Class II | Active |
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Manufacturer
- Manufacturer
- Arterys Inc.
- FDA Applicant
- Arterys, Inc.
Sources (1)
- FDA 510(k) K192437 24 fields · synced Sep 19, 2026