510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163687Substantially Equivalent

Olinda Exm

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

K163687 is the FDA 510(k) clearance record for OLINDA EXM, a class I device, cleared for Hermes Medical Solutions AB on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 17 510(k) clearances for Hermes Medical Solutions AB, from to . As of , FDA records show no recalls naming K163687.

Clearance record

Decision date
Received
(203 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Hermes Medical Solutions AB Skeppsbron 44, Stockholm, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYX

Trailing 12 months

FDA records hold no clearances under product code IYX in the trailing twelve months.

FDA records show no clearances under product code IYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260