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FDA 510(k)

3D Anatomic Model

K-Number: K230119 · 2023-05-02

ApplicantRicoh USA, Inc.
Decision Date2023-05-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Anatomic Model is a medical device manufactured by Ricoh USA, Inc.. It received FDA 510(k) clearance on 2023-05-02 under approval number K230119. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D Anatomic Model?

3D Anatomic Model is a medical device that received FDA 510(k) clearance on 2023-05-02. It is manufactured by Ricoh USA, Inc.. The 510(k) number is K230119.

When was 3D Anatomic Model approved by the FDA?

3D Anatomic Model received FDA 510(k) clearance on 2023-05-02, under approval number K230119.

What company makes 3D Anatomic Model?

3D Anatomic Model is manufactured by Ricoh USA, Inc..

What is the FDA product code for 3D Anatomic Model?

The FDA product code for 3D Anatomic Model is LLZ.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

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K2202053D Anatomic Models

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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