Cleared Special

Hybrid Viewer (00859873006240)

K252477 · Hermes Medical Solutions AB · Radiology
Sep 2025
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K252477 is an FDA 510(k) clearance for the Hybrid Viewer (00859873006240), a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on September 9, 2025, 33 days after receiving the submission on August 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K252477 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2025
Decision Date September 09, 2025
Days to Decision 33 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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