Cleared Traditional

HERMES MEDICAL IMAGING SUITE V5.3

K131233 · Hermes Medical Solutions AB · Radiology
Jul 2013
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K131233 is an FDA 510(k) clearance for the HERMES MEDICAL IMAGING SUITE V5.3, 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 July 16, 2013, 76 days after receiving the submission on May 1, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K131233 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2013
Decision Date July 16, 2013
Days to Decision 76 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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