Device Atlas

Otoplan

Q: When was Otoplan cleared by the FDA?

Otoplan (K220300) received a 510(k) decision of Substantially Equivalent on June 24, 2022, 142 days after the submission was received.

Q: What is the product code of K220300?

The FDA product code is QQE – Image Management Software For Planning Of Otologic And Neurotologic Procedures, a Class II (moderate risk) device regulated under 21 CFR 892.2050.

FDA 510(k) K220300 · Cascination AG

Substantially Equivalent

510(k) numberK220300

Submission

Device name: Otoplan
Applicant: Cascination AG
Bern, CH
Received: February 2, 2022
Decision date: June 24, 2022
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QQE – Image Management Software For Planning Of Otologic And Neurotologic Procedures
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2050
Specialty: Radiology

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

Other 510(k)s with product code QQE

510(k)	Device	Applicant	Decision
K242120	OtoplanQQE · Traditional	Cascination AG	04/11/2025SE
K203486	OtoplanQQE · Traditional	Cascination AG	08/20/2021SE

More from Cascination AG

510(k)	Device	Decision
K242120	OtoplanQQE · Traditional	04/11/2025SE
K232022	CAS-One IRJAK · Traditional	03/13/2024SE
K203486	OtoplanQQE · Traditional	08/20/2021SE
K152473	CAS-One IRJAK · Traditional	01/20/2016SE
K143024	CAS-One LiverOEW · Traditional	04/28/2015SE

Questions and answers

When was Otoplan cleared by the FDA?

Otoplan (K220300) received a 510(k) decision of Substantially Equivalent on June 24, 2022, 142 days after the submission was received.

What is the product code of K220300?

The FDA product code is QQE – Image Management Software For Planning Of Otologic And Neurotologic Procedures, a Class II (moderate risk) device regulated under 21 CFR 892.2050.