Cleared Traditional

Hybrid Viewer (00859873006189)

K241364 · Hermes Medical Solutions AB · Radiology
Nov 2024
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K241364 is an FDA 510(k) clearance for the Hybrid Viewer (00859873006189), 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 November 8, 2024, 178 days after receiving the submission on May 14, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K241364 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2024
Decision Date November 08, 2024
Days to Decision 178 days
Submission Type Traditional
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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