Radiology · 510(k) · 2019
Critical Care Suite
GE Medical Systems, LLC.. Cleared by FDA on 12 August 2019 under submission K183182, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K183182
- Device. Critical Care SuiteDEVICE
- Company. GE Medical Systems, LLC.COMPANY
- Decision. 12 August 2019, 510(k), substantially equivalent (traditional review); received 19 November 2018DECISION
- 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.
Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the x-ray image by a qualified physician. Critical Care Suite is indicated for adult-size patients.
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)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
- 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 GE Medical Systems, LLC., 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.