Cleared Traditional

K163394 - Hybrid3D

K163394 is an FDA 510(k) clearance for Hybrid3D, manufactured by Hermes Medical Solutions AB. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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

K163394 is an FDA 510(k) clearance for the Hybrid3D. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on May 22, 2017 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 - K163394

510(k) Number K163394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 249
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K163394.
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