FDA Product Code QWO: Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
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.
Leading manufacturers include Imvaria, Inc. and Imbio, Inc..
FDA 510(k) Cleared Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease. Devices (Product Code QWO)
About Product Code QWO - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QWO since 2024, with 3 receiving FDA clearance (average review time: 252 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QWO have taken an average of 149 days to reach a decision - down from 562 days historically, suggesting improved FDA processing for this classification.
QWO devices are reviewed by the Radiology panel. Browse all Radiology devices →