Cleared Traditional

K193152 - Affinity

K193152 is an FDA 510(k) clearance for Affinity, 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 93-day FDA review.

K193152 · Hermes Medical Solutions AB · Radiology device
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Feb 2020
Decision
93d
Days
Class 2
Risk

K193152 is an FDA 510(k) clearance for the Affinity. 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 February 14, 2020 after a review of 93 days - within the typical 510(k) review window.

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 - K193152

510(k) Number K193152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2019
Decision Date February 14, 2020
Days to Decision 93 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 107d · This submission: 93d
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 248
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K193152.
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