Radiology · 510(k) · 2023
BraveCX
Bering Ltd. Cleared by FDA on 9 November 2023 under submission K223754, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K223754
- Device. BraveCXDEVICE
- Company. Bering Ltd (GB)COMPANY
- Decision. 9 November 2023, 510(k), substantially equivalent (traditional review); received 15 December 2022DECISION
- 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 (15 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.
BraveCX is a radiological computer-assisted triage and notification software that analyzes adult (≥18 years old) chest X- ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). BraveCX uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case- level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, BraveCX does not send a proactive alert directly to the appropriately trained medical specialists. BraveCX is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
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.
- 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, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
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