Radiology · 510(k) · 2019
HealthPNX
Zebra Medical Vision Ltd.. Cleared by FDA on 6 May 2019 under submission K190362, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K190362
- Device. HealthPNXDEVICE
- Company. Zebra Medical Vision Ltd. (IL)COMPANY
- Decision. 6 May 2019, 510(k), substantially equivalent (traditional review); received 15 February 2019DECISION
- Panel. RadiologyPANEL
- Product code. QFM, Radiological Computer-Assisted Prioritization Software For LesionsCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Zebra Pneumothorax device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. HealthPNX analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. HealthPNX is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out Pneumothorax or otherwise preclude
The product code's definition, from FDA's classification record. Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QFM. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QFM, in Radiology, from Zebra Medical Vision Ltd., or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.