Cleared Special

HERMES MEDICAL IMAGING SUITE V5.2

K121278 · Hermes Medical Solutions AB · Radiology
Dec 2012
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K121278 is an FDA 510(k) clearance for the HERMES MEDICAL IMAGING SUITE V5.2, 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, 2012, 232 days after receiving the submission on April 30, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K121278 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2012
Decision Date December 18, 2012
Days to Decision 232 days
Submission Type Special
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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