510(k) · Radiology

HealthPNX

by Zebra Medical Vision Ltd.

HealthPNX is an AI-enabled medical device from Zebra Medical Vision Ltd. that the U.S. FDA cleared through 510(k) K190362 on May 6, 2019. Its lead review panel is Radiology and its primary product code is QFM (Radiological Computer-Assisted Prioritization Software For Lesions).

See also FDA-cleared AI radiology devices in 2019, all FDA AI clearances in 2019, top radiology AI devices.

Key facts

Submission numberK190362
Pathway510(k)
Date of final decision
Company (FDA list)Zebra Medical Vision Ltd.
Lead review panelRadiology
Primary product codeQFM — Radiological Computer-Assisted Prioritization Software For Lesions
Applicant (openFDA)Zebra Medical Vision, Ltd.
Applicant locationSefayim, IL
Device classClass 2
Regulation number21 CFR 892.2080
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. HealthPNX went through this pathway (K190362).

openFDA lists it as a Class 2 device under 21 CFR 892.2080. Class II devices are moderate risk and are subject to general and special controls.

Product code QFM covers 40 devices on the FDA AI list. By decision date, this device is #2 of 40 under that code. Zebra Medical Vision Ltd. has 9 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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