RICOH 3D for Healthcare Regulatory Information
Quality
Ricoh 3D for Healthcare is committed to providing innovative high-quality products and services that meet or exceed customer expectations, including:
Focus on continuous improvement of our products, processes and services, to meet our quality objectives
Understanding the customer’s requirements and meeting their needs
Shared involvement of all team members in the delivery of quality products and services, and maintaining the effectiveness of our quality management system
Meeting all current applicable regulatory requirements
To this point, Ricoh 3D for Healthcare maintains certification to ISO 13485:2016, Medical Devices – Quality Management Systems – Requirements for Regulatory Purpose.
Anatomic Model Regulatory Information
Ricoh 3D Anatomic Models are intended as physical replicas of patient anatomy to be used for diagnostic purposes in the fields of craniomaxillofacial, orthopedic, cardiovascular, neurological, gastrointestinal, genitourinary, and breast applications. The Anatomic Models are based on DICOM imaging information from a medical scanner and output files from FDA cleared software intended for the creation and output of digital files suitable for the fabrication of physical replicas. The models should be used in conjunction with other diagnostic tools and expert clinical judgement.
The accuracy of the Anatomic Model to patient anatomy is determined largely by the quality of the medical imaging data. It is recommended that users consult the following Scanning Protocols for best results:
The following information describes the supported printers, materials, applications, and imaging input for Ricoh 3D Anatomic Models:
| Printer Manufacturer |
Technology | Model | Material | Applications | Imaging Input |
|---|---|---|---|---|---|
| Stratasys | Polyjet | J750/J850 | VeroMagenta, VeroYellow, VeroClear, VeroBlackPlus, VeroPureWhite, VeroCyan, BoneMatrix, GelMatrix1, Tissue Matrix1, Agilus1 |
Craniomaxillofacial Orthopedic Cardiovascular Cardiovascular Neurological Genitourinary Gastrointestinal Breast |
CT CT, MRI CT, MRI CT, MRI CT, MRI CT, MRI MRI |
| J5 MediJet | VeroBlackPlus, VeroPureWhite, VeroYellow, VeroCyan, VeroMagenta, VeroUltraClear, VereUltraWhite, DraftWhite |
Craniomaxillofacial Orthopedic Cardiovascular Neurological Genitourinary Gastrointestinal Breast |
CT CT, MRI CT, MRI CT, MRI CT, MRI CT, MRI MRI |
||
| FDM | F3702 | ABS-M30 White |
Craniomaxillofacial Orthopedic Cardiovascular Neurological Genitourinary Gastrointestinal |
CT CT, MRI CT, MRI CT, MRI CT, MRI CT, MRI |
- 1.Thin-walled anatomy available in lower-durometer materials with Shore A Hardness of 95 or greater.
- 2.Stratasys F370 is a single material FDM print technology. Therefore, it is not suitable for models in which distinction between fully/partially encapsulated tissue and surrounding tissue and/or bone is desired.