Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3D Anatomic Models

K-Number: K220205 · 2022-06-03

ApplicantRicoh USA, Inc.
Decision Date2022-06-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D Anatomic Models is a medical device manufactured by Ricoh USA, Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval 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. It is manufactured by Ricoh USA, Inc.. The 510(k) number is K220205.

When was 3D Anatomic Models approved by the FDA?

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

What company makes 3D Anatomic Models?

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

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

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

Other Devices by Ricoh USA, Inc.

K2301193D Anatomic Model

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑