Cleared Traditional

K163687 - OLINDA EXM

K163687 is an FDA 510(k) clearance for OLINDA EXM, manufactured by Hermes Medical Solutions AB. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K163687 · Hermes Medical Solutions AB · Radiology device
Download Printable Device Report (PDF)
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Jul 2017
Decision
203d
Days
Class 1
Risk

K163687 is an FDA 510(k) clearance for the OLINDA EXM. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on July 19, 2017 after a review of 203 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hermes Medical Solutions AB devices

FDA 510(k) Submission Details - K163687

510(k) Number K163687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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All 65
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