Cleared Traditional

Hermes Medical Imaging Suite v5.6

K153056 · Hermes Medical Solutions AB · Radiology
Jun 2016
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K153056 is an FDA 510(k) clearance for the Hermes Medical Imaging Suite v5.6, 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 June 1, 2016, 224 days after receiving the submission on October 21, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K153056 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2015
Decision Date June 01, 2016
Days to Decision 224 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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