510(k) · Radiology

aPROMISE X

by EXINI Diagnostics AB

aPROMISE X is an AI-enabled medical device from EXINI Diagnostics AB that the U.S. FDA cleared through 510(k) K220590 on April 29, 2022. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2022, all FDA AI clearances in 2022, top radiology AI devices.

Key facts

Submission numberK220590
Pathway510(k)
Date of final decision
Company (FDA list)EXINI Diagnostics AB
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Exini Diagnostics AB
Applicant locationLund, SE
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. aPROMISE X went through this pathway (K220590).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #110 of 161 under that code. EXINI Diagnostics AB has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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