Expd 86p, Expd 86pg, Expd 129p, Expd 129pg
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223124 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 EXPD 86P, EXPD 86PG, EXPD 129P, and EXPD 129PG are Solid State X-Ray Imagers (Flat Panel/Digital Imagers). These devices convert X-ray exposure into digital signals for real-time radiographic imaging, enabling high-resolution visualization of human anatomy. They are designed to replace traditional film or screen-based radiographic systems, providing immediate diagnostic imaging for general radiology procedures.
These imagers are intended for use in radiology settings and are supplied as reusable medical devices. They are classified under product code MQB and comply with FDA 510(k) clearance (K223124) and MDR regulations. The devices are intended for general radiographic diagnosis and are not single-use. No specific MRI safety information is provided, and storage conditions are not detailed in the regulatory data.
Frequently asked questions
Are these devices single-use or reusable, and how does that affect their maintenance requirements?
The EXPD 86P, EXPD 86PG, EXPD 129P, and EXPD 129PG are reusable solid-state X-ray imagers, meaning they are designed for repeated use in radiology settings. Since they are not single-use, they require proper cleaning, calibration, and maintenance protocols to ensure consistent performance and image quality over time. The manufacturer’s instructions should outline these procedures to comply with regulatory and clinical standards.
What types of radiographic procedures are these devices intended for, and how do they improve upon traditional film-based systems?
These devices are intended for general radiographic diagnosis in radiology settings, replacing traditional film or screen-based systems. They convert X-ray exposure into high-resolution digital signals, enabling real-time imaging and immediate diagnostic visualization of human anatomy. This eliminates the need for chemical processing and reduces patient wait times compared to film-based systems.
What regulatory pathways have these devices undergone, and how does that affect their use in clinical settings?
The EXPD series has undergone FDA 510(k) clearance (K223124) and complies with MDR (Medical Device Regulation) requirements. This means they meet U.S. and EU regulatory standards for safety and performance, allowing their use in clinical radiology settings where digital imaging is required. The clearance is specific to general radiographic diagnosis, not single-use applications.
Are there any specific storage requirements or considerations for these devices?
The provided regulatory data does not detail specific storage conditions for these reusable X-ray imagers. However, as reusable medical devices, they should be stored in a clean, dry environment to prevent contamination or damage. The manufacturer’s guidelines likely include recommendations for handling, calibration, and environmental protection to maintain functionality and sterility before use.
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: EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG (K223124) — FDA 510 (k ..., K223124 FDA 510 (k) - EXPD 86P | DRTECH Corporation, EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG (K223124) — FDA 510 (k ...
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 | K223124 | Class II | Active |
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Manufacturer
- Manufacturer
- DRTECH Corporation
Sources (2)
- FDA 510(k) K223124 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026