Cleared Traditional

Affinity

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

About This 510(k) Submission

K193152 is an FDA 510(k) clearance for the Affinity, 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 February 14, 2020, 93 days after receiving the submission on November 13, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K193152 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

Similar Devices — KPS System, Tomography, Computed, Emission

All 468
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
K253564 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
K254001 · Spectrum Dynamics Medical, Ltd. · Jan 2026
AnyScan 3.0 NM Scanner Family
K253844 · Mediso Medical Imaging Systems, Ltd. · Dec 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · Canon Medical Systems Corporation · Dec 2025
PennPET Explorer Positron Emission Tomograph
K251401 · Trustees of the University of Pennsylvania · Nov 2025
Hybrid Viewer (00859873006240)
K252477 · Hermes Medical Solutions AB · Sep 2025