Cleared Traditional

Hybrid3D

K163394 · Hermes Medical Solutions AB · Radiology
May 2017
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K163394 is an FDA 510(k) clearance for the Hybrid3D, 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 May 22, 2017, 168 days after receiving the submission on December 5, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K163394 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2016
Decision Date May 22, 2017
Days to Decision 168 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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