Radiology · 510(k) · 2020
HealthMammo
Zebra Medical Vision Ltd.. Cleared by FDA on 16 July 2020 under submission K200905, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K200905
- Device. HealthMammoDEVICE
- Company. Zebra Medical Vision Ltd. (IL)COMPANY
- Decision. 16 July 2020, 510(k), substantially equivalent (traditional review); received 6 April 2020DECISION
- 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 (10 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 HealthMammo is a passive notification for prioritization -only, parallel -workflow software tool used by MQSA -qualified interpreting physician s to prioritize patients with suspicious findings in the medical care environment. HealthMammo utilizes an artificial intelligence algorithm to analyze 2D FFDM screening mammograms and flags those that are suggestive of the presence of at least one suspicious finding at the exam -level. HealthMammo produces an exam-level output to a PACS/Workstation for flagging the suspicious case and allows worklist prioritization. MQSA-qualified interpreting physicians are responsible for reviewing each exam on a display approved for use in mammography according to the current standard of care. HealthMammo device is limited to the categorization of exams, does not provide any diagnostic information beyond triage and prioritization, does not remove images from the interpreting physician ’s Zebra Medical Vision Ltd. 5-3 worklist, and should not be used in lieu of full patient evaluation, or relied upon to make or confirm diagnosis. The HealthMammo device is intended for use with complete 2D FFDM mammography exams acquired using validated FFDM systems only.
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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
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 2020. 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.