Cleared Traditional

Vision 2, EVARVision, TrackVision 2, HeartVision 2

K223152 · GE Medical Systems SCS · Radiology
Nov 2022
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K223152 is an FDA 510(k) clearance for the Vision 2, EVARVision, TrackVision 2, HeartVision 2, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on November 22, 2022, 47 days after receiving the submission on October 6, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K223152 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 2022
Decision Date November 22, 2022
Days to Decision 47 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050