Cleared Traditional

Image Suite

K251168 · Carestream Health, Inc. · Radiology
Sep 2025
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K251168 is an FDA 510(k) clearance for the Image Suite, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on September 4, 2025, 142 days after receiving the submission on April 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K251168 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2025
Decision Date September 04, 2025
Days to Decision 142 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