Cleared Traditional

qXR-PTX-PE

K230899 · Qure.Ai Technologies · Radiology
Aug 2023
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K230899 is an FDA 510(k) clearance for the qXR-PTX-PE, a Radiological Computer-assisted Prioritization Software For Lesions (Class II — Special Controls, product code QFM), submitted by Qure.Ai Technologies (Mumbai, IN). The FDA issued a Cleared decision on August 22, 2023, 144 days after receiving the submission on March 31, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number K230899 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date August 22, 2023
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QFM — Radiological Computer-assisted Prioritization Software For Lesions
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2080
Definition 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.