Cleared Traditional

K221680 - Xeleris V Processing and Review System
(FDA 510(k) Clearance)

K221680 · Ge Healthcare · Radiology
Mar 2023
Decision
265d
Days
Class 2
Risk

K221680 is an FDA 510(k) clearance for the Xeleris V Processing and Review System, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on March 1, 2023, 265 days after receiving the submission on June 9, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K221680 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2022
Decision Date March 01, 2023
Days to Decision 265 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