Cleared Traditional

Critical Care Suite

K183182 · Ge Medical Systems, LLC · Radiology
Aug 2019
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K183182 is an FDA 510(k) clearance for the Critical Care Suite, a Radiological Computer-assisted Prioritization Software For Lesions (Class II — Special Controls, product code QFM), submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on August 12, 2019, 266 days after receiving the submission on November 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2080.

Submission Details

510(k) Number K183182 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2018
Decision Date August 12, 2019
Days to Decision 266 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.