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Ezra Flash

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230264

by Ezra Ai, Inc.

Identifiers

510(k) Number
K230264 FDA 510(k)
FDA Product Code
LLZ 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)

Ezra Flash is an AI-enabled medical imaging device designed for use in radiology procedures. It functions as an adjunct to MRI systems, leveraging artificial intelligence to enhance image quality and processing efficiency. The device is classified under the product code QIH as a Class 2 Radiology device, intended to assist in diagnostic imaging workflows.

Ezra Flash is supplied as a software-based solution integrated with MRI systems, requiring no additional sterility or single-use considerations. It operates within MRI-safe environments and is intended for use in clinical settings where radiology imaging is performed. The device holds FDA 510(k) clearance (K242334) under the Traditional pathway, with a review by the Radiology Advisory Committee. No specific size or storage requirements are noted beyond standard MRI-compatible infrastructure.

Frequently asked questions

What is Ezra Flash designed to do in radiology procedures?

Ezra Flash is an AI-enabled medical imaging device designed to assist radiologists by improving MRI image quality and processing efficiency. It acts as a software-based adjunct to MRI systems, helping streamline diagnostic workflows without requiring additional hardware or sterility measures.

How is Ezra Flash supplied and does it require sterility?

Ezra Flash is supplied as a software solution integrated with MRI systems. Since it is not a physical device or consumable, there are no sterility requirements or single-use considerations—it operates within existing MRI-compatible environments.

Is Ezra Flash compatible with all MRI systems?

Ezra Flash is designed to function as an adjunct to MRI systems, but compatibility depends on the specific MRI platform’s software infrastructure. The manufacturer ensures integration with standard MRI-compatible setups, though users should verify compatibility with their equipment before deployment.

What regulatory pathway does Ezra Flash follow?

Ezra Flash received FDA 510(k) clearance under the Traditional pathway, with review by the Radiology Advisory Committee. The device is classified as a Class 2 Radiology product under product code QIH, indicating it is substantially equivalent to a legally marketed predicate.

Are there specific storage or environmental requirements for Ezra Flash?

Ezra Flash does not have unique storage requirements beyond those of standard MRI-compatible infrastructure. It operates within MRI-safe environments, so no additional environmental controls (e.g., temperature, humidity) are specified beyond typical clinical radiology settings.

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: Ezra obtains new FDA 510(k) clearance for Ezra Flash AI, making MRI ..., Ezra AI, Inc.: Ezra Flash (FDA-cleared AI medical device), K242334 FDA 510 (k) - Ezra Flash | Ezra Ai, Inc., Ezra Receives 510(k) FDA Clearance For AI That Enhances MRI, Enabling ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ezra Ai, Inc.

Sources (1)

  • FDA 510(k) K230264 24 fields · synced Oct 1, 2026