YosemiteView 4343W/YosemiteView 3643W
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232058 FDA 510(k)
- FDA Product Code
- MQB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The YosemiteView 4343W and YosemiteView 3643W are Solid State X-Ray Imagers (Flat Panel/Digital Imagers). These devices convert X-ray exposure into digital signals, enabling real-time radiographic imaging for diagnostic purposes in radiology. Their flat-panel design allows for high-resolution, high-contrast images essential for evaluating skeletal structures, soft tissues, and vascular systems.
These imagers are intended for use in radiology departments, hospitals, and clinical settings where digital X-ray imaging is required. They are supplied as reusable medical devices and are classified under FDA device class II. The devices are regulated under the FDA 510(k) clearance and MDR, with specific compliance to regulation number 892.1680. They are not single-use and require proper sterilization and maintenance protocols as outlined by the manufacturer.
Frequently asked questions
Are the YosemiteView 4343W and YosemiteView 3643W imagers designed for single-use or reusable applications in clinical settings?
The YosemiteView 4343W and YosemiteView 3643W are explicitly classified as reusable medical devices. Since they are not single-use, they require proper sterilization and maintenance protocols as outlined by the manufacturer to ensure safety and performance in radiology departments, hospitals, and clinical settings.
What types of anatomical structures or systems are these imagers primarily used to evaluate, and why is their flat-panel design important?
These imagers are designed for high-resolution, high-contrast digital radiographic imaging, making them ideal for evaluating skeletal structures, soft tissues, and vascular systems. The flat-panel design enables real-time imaging with superior clarity, which is critical for accurate diagnostic assessments in radiology.
How are these devices regulated, and what does the FDA’s classification mean for their use in clinical practice?
The YosemiteView 4343W and YosemiteView 3643W are classified under FDA device class II and have received 510(k) clearance, meaning they are deemed substantially equivalent to a legally marketed predicate device. This classification ensures they meet established safety and effectiveness standards for use in radiology departments and clinical settings where digital X-ray imaging is required.
What regulatory compliance standards do these imagers adhere to, and how does this impact their implementation in healthcare facilities?
These devices comply with FDA regulation number 892.1680 and are also subject to MDR (Medical Device Regulation) standards. This compliance ensures they meet stringent requirements for performance, safety, and quality, which healthcare facilities must verify before integration into their radiology workflows.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232058 | Class II | Active |
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Manufacturer
- Manufacturer
- Careray Digital Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K232058 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026