3D Anatomic Models

System, Image Processing, Radiological

Ricoh USA, Inc.

The following data is part of a premarket notification filed by Ricoh Usa, Inc. with the FDA for 3d Anatomic Models.

Pre-market Notification Details

Device IDK220205
510k NumberK220205
Device Name:3D Anatomic Models
ClassificationSystem, Image Processing, Radiological
Applicant Ricoh USA, Inc. 5575 Venture Drive Unit A Parma,  OH  44130
ContactGary Turner
CorrespondentScott Brewer
Ricoh USA, Inc. 5575 Venture Drive Unit A Parma,  OH  44130
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-25
Decision Date2022-06-03

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