Cleared Traditional

AnyScan 3.0 NM Scanner Family

K253844 · Mediso Medical Imaging Systems, Ltd. · Radiology

Dec 2025

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K253844 is an FDA 510(k) clearance for the AnyScan 3.0 NM Scanner Family, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Mediso Medical Imaging Systems, Ltd. (Budapest, HU). The FDA issued a Cleared decision on December 30, 2025, 28 days after receiving the submission on December 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K253844 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 2025
Decision Date	December 30, 2025
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF