Patient Specific Planning Solution 3D Bone Models

Q: What is the product code of K230540?

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

FDA 510(k) K230540 · Biomet Manufacturing Corp

Substantially Equivalent

510(k) numberK230540

Submission

Device name: Patient Specific Planning Solution 3D Bone Models
Applicant: Biomet Manufacturing Corp
Warsaw, IN, US
Received: February 27, 2023
Decision date: July 25, 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

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K262449	AdvaViewLLZ · Special	Advahealth Solutions, LLC	08/14/2026SE
K261916	NeuroQuant PETLLZ · Traditional	Cortechs Labs, Inc.	08/12/2026SE
K260936	RadioViewAILLZ · Traditional	Neurocareai, Inc. (Dba Savelife.Ai)	07/31/2026SE
K260588	Cleerly LABSLLZ · Traditional	Cleerly, Inc.	07/29/2026SE
K262462	TheraSphere 360 Y-90 Management PlatformLLZ · Special	Boston Scientific Corporation	07/24/2026SE
K262143	ImageGrid StreamVueLLZ · Traditional	Candelis, Inc.	07/23/2026SE
K260500	ResolutionMDLLZ · Traditional	ResolutionMD, Inc.	07/21/2026SE
K262120	Avara ViewerLLZ · Traditional	Avara Software	07/10/2026SE

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Questions and answers

When was Patient Specific Planning Solution 3D Bone Models cleared by the FDA?

Patient Specific Planning Solution 3D Bone Models (K230540) received a 510(k) decision of Substantially Equivalent on July 25, 2023, 148 days after the submission was received.

What is the product code of K230540?

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

Patient Specific Planning Solution 3D Bone Models