Cleared Traditional

AV Viewer

K250181 · Philips Medical Systems Nederland B.V. · Radiology
Jul 2025
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K250181 is an FDA 510(k) clearance for the AV Viewer, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on July 15, 2025, 174 days after receiving the submission on January 22, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K250181 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2025
Decision Date July 15, 2025
Days to Decision 174 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