Cleared Traditional

OLINDA EXM

K163687 · Hermes Medical Solutions AB · Radiology
Jul 2017
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K163687 is an FDA 510(k) clearance for the OLINDA EXM, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on July 19, 2017, 203 days after receiving the submission on December 28, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K163687 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2016
Decision Date July 19, 2017
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYX — Camera, Scintillation (gamma)
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1100

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