Identifiers
- 510(k) Number
- K230119 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A 3D Anatomic Model is a device used to represent anatomical structures for medical visualization and planning purposes. It is designed to assist healthcare professionals in understanding patient-specific anatomy through physical or digital three-dimensional representation.
The device is supplied as a non-sterile, reusable or single-use model depending on the specific configuration, intended for use in clinical settings such as hospitals or imaging centers. It is not indicated for implantation or direct patient contact in a therapeutic capacity, and its use is governed by the FDA 510(k) clearance under product code LLZ, with no claims of sterility, MRI safety, or specific storage conditions provided in the data.
Frequently asked questions
What is the 3D Anatomic Model used for?
The 3D Anatomic Model is used to represent anatomical structures for medical visualization and planning purposes, helping healthcare professionals understand patient-specific anatomy through physical or digital three-dimensional representation in clinical settings such as hospitals or imaging centers.
Is the 3D Anatomic Model sterile or single-use?
The device is supplied as non-sterile and can be either reusable or single-use depending on the specific configuration; it is not indicated for implantation or direct patient contact in a therapeutic capacity, and no claims of sterility are made in the provided data.
What regulatory pathway was used for the 3D Anatomic Model?
The 3D Anatomic Model received FDA 510(k) clearance under product code LLZ, with a traditional clearance type and a substantially equivalent decision, as indicated by the decision code SESE and decision date of May 2, 2023.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230119 | Class II | Active |
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Manufacturer
- Manufacturer
- Ricoh USA, Inc.
Sources (1)
- FDA 510(k) K230119 24 fields · synced Sep 27, 2026