FDA 510(k)

3D Anatomic Models

K-Number: K220205 · 2022-06-03

Decision Date2022-06-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D Anatomic Models is the device name listed in this FDA 510(k) record. The listed applicant is Ricoh USA, Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220205. 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 Models?

3D Anatomic Models is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Ricoh USA, Inc.. The 510(k) number is K220205.

When did 3D Anatomic Models receive FDA 510(k) clearance?

3D Anatomic Models received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220205.

Who is the listed applicant for 3D Anatomic Models?

The FDA 510(k) record lists Ricoh USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Ricoh USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2301193D Anatomic Model

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Official Source

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