510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193152Substantially Equivalent

Affinity

Hermes Medical Solutions AB, Stockholm, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193152 is the FDA 510(k) clearance record for Affinity, a class II device, cleared for Hermes Medical Solutions AB on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list 17 510(k) clearances for Hermes Medical Solutions AB, from to . As of , FDA records show no recalls naming K193152.

Clearance record

Decision date
Received
(93 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Hermes Medical Solutions AB Strandbergsgatan 16, Stockholm, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPS

Trailing 12 months
9 clearances under product code KPS in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
November 20251
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260