Cleared Traditional

Hybrid3D

K181468 · Hermes Medical Solutions AB · Radiology
Oct 2018
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K181468 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 October 25, 2018, 143 days after receiving the submission on June 4, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K181468 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2018
Decision Date October 25, 2018
Days to Decision 143 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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