Jazz

FDA 510(k) K223659 · Ai Medical AG

Substantially Equivalent

510(k) numberK223659

Submission

Device name
Jazz
Applicant
Ai Medical AG
Zollikon, CH
Received
December 6, 2022
Decision date
September 22, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

Other 510(k)s with product code LLZ

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K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
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K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
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K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

Questions and answers

When was Jazz cleared by the FDA?

Jazz (K223659) received a 510(k) decision of Substantially Equivalent on September 22, 2023, 290 days after the submission was received.

What is the product code of K223659?

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