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510(k) K203486

Otoplan by Cascination AG — Product Code QQE

K203486 is an FDA 510(k) premarket notification submitted by Cascination AG for the device "Otoplan". The FDA issued a decision of Substantially Equivalent on August 20, 2021. The device falls under product code QQE (Image Management Software For Planning Of Otologic And Neurotologic Procedures), a Class II device regulated under 21 CFR 892.2050. Cascination AG has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2021
Date Received
November 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image Management Software For Planning Of Otologic And Neurotologic Procedures
Device Class
Class II
Regulation Number
892.2050
Review Panel
EN
Submission Type

Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.

Other clearances by Cascination AG

  • K242120 — OTOPLAN (April 11, 2025)
  • K232022 — CAS-One IR (March 13, 2024)
  • K220300 — OTOPLAN (June 24, 2022)
  • K152473 — CAS-One IR (January 20, 2016)
  • K143024 — CAS-One Liver (April 28, 2015)

Other clearances for product code QQE

  • K242120 — OTOPLAN (April 11, 2025)
  • K220300 — OTOPLAN (June 24, 2022)

FDA data resources