Cleared Traditional

View

K253639 · Ge Healthcare · Radiology
Jan 2026
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K253639 is an FDA 510(k) clearance for the View, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Ge Healthcare (Chicago, US). The FDA issued a Cleared decision on January 8, 2026, 50 days after receiving the submission on November 19, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253639 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2025
Decision Date January 08, 2026
Days to Decision 50 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