Radiology · 510(k) · 2025
ScreenDx
Imvaria, Inc. Cleared by FDA on 10 January 2025 under submission K241891, product code QWO (radiology software for referral of findings related to fibrotic lung disease.). What FDA's record says, in FDA's words.
Device record · K241891
- Device. ScreenDxDEVICE
- Company. Imvaria, IncCOMPANY
- Decision. 10 January 2025, 510(k), substantially equivalent (traditional review); received 28 June 2024DECISION
- Panel. RadiologyPANEL
- Product code. QWO, Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.CODE
- Regulation. 21 CFR 892.2085, Class IIREG
- Source. FDA database entry · decision document (19 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.
ScreenDx is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to assess for interstitial lung findings compatible with interstitial lung disease. The device supplements the standard-of-care workflow by providing a qualitative output of imaging findings based on pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriately qualified clinician. Patients with positively identified patterns may undergo assessment for lung fibrosis, but ScreenDx does not replace the current standard of care methods for diagnosis of lung fibrosis and the results of the device are not intended to rule-out or rule-in lung fibrosis. The results of ScreenDx are intended to be used only by clinicians qualified in the care of lung disease, in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment. The input to ScreenDx is a DICOM-compliant lung CT scan. Clinical case eligibility includes the following criteria: • Age > 22 years old.
The product code's definition, from FDA's classification record. Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
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 namedCT
- Mentionsan adjunct to the clinician, not a replacement
- 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 QWO. 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 QWO, in Radiology, from Imvaria, Inc, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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