AiMIFY (1.x)

Trade Name

AiMIFY

Generic Name

Radiology DICOM image processing application software

Model / Reference

1.x

Primary DI / UDI-DI

00860000171298

Basic UDI-DI

08600001712AiMIFY13H

510(k) Number

K240290 ↗

FDA Product Code

LLZ

EMDN Code

Z11030582 Radiology instruments - software accessories

GMDN Term

Radiology DICOM image processing application software

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.2050

Special Device Type

Software

Market of Registration

Italy

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

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See all devices from Subtle Medical, Inc. →

• What specific types of brain MRI scans can AiMIFY (1.x) enhance, and how does it improve diagnostic accuracy for radiologists?

  AiMIFY (1.x) is designed to enhance brain MRI scans acquired using gadolinium-based contrast agents. It improves diagnostic accuracy by increasing the contrast-to-noise ratio, contrast enhancement, and lesion-to-brain ratio. These enhancements help radiologists better visualize and differentiate lesions or abnormalities in the brain, making it particularly useful for post-processing scans where clarity is critical.

• Is AiMIFY (1.x) a standalone device, or does it require integration with existing MRI systems? If so, what does this mean for compatibility?

  AiMIFY (1.x) is supplied as software and is not a standalone device—it requires integration with existing MRI systems. Compatibility depends on the technical specifications of the host MRI system, as the software is designed to work within those systems' post-processing workflows. Buyers should verify their MRI system’s compatibility before implementation.

• How is AiMIFY (1.x) intended to be used in a clinical setting, and what are the key considerations for its application?

  AiMIFY (1.x) is intended for single-use applications in radiology settings, specifically for post-processing MRI scans of the brain that use gadolinium-based contrast agents. Since it is software-based, its use depends entirely on the host MRI system’s ability to support its integration. Clinicians should ensure their workflows accommodate its post-processing role, as it does not replace the MRI scanner itself but refines the resulting images.

• What regulatory pathways does AiMIFY (1.x) follow, and what does this mean for healthcare providers considering its adoption?

  AiMIFY (1.x) holds FDA 510(k) clearance and MDR authorization, indicating it has undergone regulatory review for safety and effectiveness. The device was filed under K240290 and classified under product code LLZ (Radiology), with a decision of substantial equivalence by the Radiology Advisory Committee. This means it has been deemed comparable to a legally marketed predicate device, providing assurance of its regulatory compliance for use in clinical settings.