510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203486Substantially Equivalent

Otoplan

Cascination, Bern, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203486 is the FDA 510(k) clearance record for Otoplan, a class II device, cleared for Cascination AG on under FDA product code QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures). FDA's definition for product code QQE reads: "Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures". FDA records list 6 510(k) clearances for Cascination AG, from to . As of , FDA records show no recalls naming K203486.

Clearance record

Decision date
Received
(266 days to decision)
Product code
QQE Image Management Software For Planning Of Otologic And Neurotologic Procedures
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Cascination AG Steigerhubelstrasse 3, Bern, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQE

Trailing 12 months

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

FDA records show no clearances under product code QQE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQE, 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