510(k) · Radiology

AMRA Profiler

by AMRA Medical AB

AMRA Profiler is an AI-enabled medical device from AMRA Medical AB that the U.S. FDA cleared through 510(k) K173749 on December 6, 2018. Its lead review panel is Radiology and its primary product code is LNH (System, Nuclear Magnetic Resonance Imaging).

See also FDA-cleared AI radiology devices in 2018, all FDA AI clearances in 2018, top radiology AI devices.

Key facts

Submission numberK173749
Pathway510(k)
Date of final decision
Company (FDA list)AMRA Medical AB
Lead review panelRadiology
Primary product codeLNH — System, Nuclear Magnetic Resonance Imaging
Applicant (openFDA)Amra Medical AB
Applicant locationLinkoping, SE
Device classClass 2
Regulation number21 CFR 892.1000
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. AMRA Profiler went through this pathway (K173749).

openFDA lists it as a Class 2 device under 21 CFR 892.1000. Class II devices are moderate risk and are subject to general and special controls.

Product code LNH covers 100 devices on the FDA AI list. By decision date, this device is #2 of 100 under that code. AMRA Medical AB has 1 AI-enabled device 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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