Identifiers
- 510(k) Number
- K113442 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)
3Di is a medical image management and advanced visualization system designed for breast imaging centers. It provides image processing, visualization, and communication technologies that allow for the viewing of 2D or 3D images from various vendors.
This device is intended for use in clinical settings such as hospitals and teleradiology centers to support diagnostic workflows. It has received FDA 510(k) clearance under the product code LLZ.
Frequently asked questions
What is the primary function of the 3Di system?
The 3Di system is designed as an advanced visualization and image management platform for breast imaging centers. It enables clinicians to process, visualize, and communicate both 2D and 3D medical images sourced from various vendors to support diagnostic workflows.
In what clinical environments can the 3Di system be used?
The device is intended for use in professional clinical settings, specifically hospitals and teleradiology centers, where it serves to facilitate the management and review of breast imaging data.
What is the regulatory status of the 3Di system?
The 3Di system has received FDA 510(k) clearance under the product code LLZ. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.
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. Sources consulted: Shina Systems | Medical Image Management and Advanced Visualization, Medical Image Management and Advanced Visualization by Shina Systems, Shina Systems | Solutions | 3Di Image Management and Advanced Visualization, K112530 FDA 510(k) - 3DI INCLUDING CSCORE | Shina Systems , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113442 | Class II | Active |
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Manufacturer
- Manufacturer
- Shina Systems , Ltd.
Sources (1)
- FDA 510(k) K113442 24 fields · synced Sep 25, 2026