Cube Navigator

FDA 510(k) K240620 · Medical Templates AG

Substantially Equivalent

510(k) numberK240620

Submission

Device name
Cube Navigator
Applicant
Medical Templates AG
Egg, CH
Received
March 5, 2024
Decision date
March 25, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Cube Navigator cleared by the FDA?

Cube Navigator (K240620) received a 510(k) decision of Substantially Equivalent on March 25, 2024, 20 days after the submission was received.

What is the product code of K240620?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.