Cleared Traditional

Hermes Medical Imaging Suite v5.5

K142631 · Hermes Medical Solutions AB · Radiology
Dec 2014
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K142631 is an FDA 510(k) clearance for the Hermes Medical Imaging Suite v5.5, 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 December 18, 2014, 92 days after receiving the submission on September 17, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K142631 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2014
Decision Date December 18, 2014
Days to Decision 92 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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