Cleared Traditional

Affinity

K202882 · Hermes Medical Solutions AB · Radiology
Dec 2020
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K202882 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 December 23, 2020, 86 days after receiving the submission on September 28, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K202882 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2020
Decision Date December 23, 2020
Days to Decision 86 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

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