RICOH 3D for Healthcare receives Expanded FDA 510(k) Clearance for Anatomical 3D Modeling of Soft Tissues

Ricoh USA has announced that RICOH 3D for Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new areas of patient-specific anatomical modeling for diagnostic applications.

Ricoh previously received FDA approval for patient-specific anatomical modeling in the craniomaxillofacial (CMF) and orthopedic areas in June 2022. The expanded clearance enables Ricoh to support more surgical specialties and patient diagnoses, and to print diagnostic-quality 3D anatomical models of bone and soft tissue using Stratasys 3D printing technology and materials.

“Receiving the expanded 510(k) clearance for anatomic modeling of soft tissue is an exciting milestone for Ricoh as we continue to lead the way in offering democratized access to patient-specific 3D-printed models in healthcare,” said Gary Turner, managing director, Additive Manufacturing, North America, Ricoh USA, Inc. “As a manufacturer of precision additive medical devices, Ricoh offers one of the broadest scopes of FDA-cleared 3D models for anatomic regions and a wide range of print materials available for diagnostic use – which combine to improve outcomes, enhance the patient experience and increase opportunities for physician education and training.”

The end-to-end workflow solution integrates with Merge Universal Viewer, an enterprise imaging solution from Merative (formerly IBM Watson Health) used in many hospitals across the United States. The integration capabilities allow providers to request 3D-printed anatomical models through Ricoh’s centralized print and ship solution and deliver them the same week, or produce the models at a Ricoh-managed point-of-care production facility on-site at the healthcare facility and deliver them the next day.

“Ricoh’s ability to 3D print various materials – now expanded to additional areas of anatomy under the new 510(k) – will assist our care team in better understanding what surgeons and interventionalists can expect to see in the operating room before they ever step foot inside,” said Dr. Vishal Gupta, Co-Chair, Ascension Borgess Heart Institute. “Patient-specific models for diagnostic purposes are crucial in pre-surgical planning and can also support clinicians in better educating patients about what procedures will entail – something we recently did for a case.”

Ricoh 3D for Healthcare produces patient-specific anatomical models via additive manufacturing using segmented 3D printed files created from medical images in FDA-approved applications. These models are used for diagnostic purposes in various medical fields. With the ability to manage 3D printing operations at the point of care, Ricoh 3D for Healthcare provides a streamlined and efficient solution for producing these models.

Find out more about Ricoh USA at ricoh-usa.com.