6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF Solid State X-Ray Imager
by Pzmedical Technology Co., Ltd.
510(k) K212105
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212105 | Date23 Aug 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
- 510(k) Number
- FDA Product Code
- MQB
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed to capture and display radiographic images for diagnostic purposes. It employs solid-state detector technology to convert X-ray exposure into digital signals, enabling high-resolution imaging in radiology applications. The imager is intended for use in medical environments requiring precise and efficient radiographic visualization, such as hospitals, clinics, and diagnostic centers.
The 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF models are supplied as reusable medical devices and are classified under FDA product code MQB as Class II devices under Regulation 892.1680. They are intended for use in radiology settings and have received FDA 510K clearance as substantially equivalent to predicate devices. Each model number corresponds to specific configurations or sizes, as detailed in the regulatory submission.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, and 3025ZF models?
These models are solid-state X-ray imagers designed to capture and display high-resolution radiographic images for diagnostic purposes in radiology settings. They convert X-ray exposure into digital signals, enabling precise visualization in hospitals, clinics, and diagnostic centers. Each model corresponds to specific configurations or sizes, ensuring compatibility with various clinical workflows.
Are these devices single-use or reusable?
These devices are reusable medical devices. They are intended for repeated use in radiology environments, provided they are properly maintained and processed according to manufacturer guidelines. Reusability helps reduce waste and costs while maintaining diagnostic quality.
What regulatory clearance do these imagers hold?
The 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, and 3025ZF models have received FDA 510K clearance as substantially equivalent to predicate devices. This clearance confirms their compliance with U.S. regulatory standards for Class II medical devices under product code MQB, ensuring safety and performance for radiographic imaging.
How do the different model numbers differ?
Each model number (e.g., 6543Z, 3025ZF) corresponds to specific configurations or sizes tailored for different radiographic applications. While the exact specifications vary, they all share the same solid-state detector technology for high-resolution imaging. The manufacturer’s documentation details the precise dimensions, field of view, and technical features for each model to guide selection based on clinical needs.
What maintenance or storage requirements apply to these reusable imagers?
As reusable devices, these imagers must be cleaned, disinfected, and inspected between uses to prevent contamination and ensure image quality. Storage should follow manufacturer recommendations, typically in a clean, dry environment protected from physical damage or extreme temperatures. Proper maintenance protocols are critical to sustaining performance and compliance with regulatory standards.