DFP4343C7 X-Ray System
510(k) K122589
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122589 | Date5 Oct 2012 | 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- Withdrawn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
- DFP4343C7
- 510(k) Number
- FDA Product Code
- KPR
- 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
The DFP4343C7 is a stationary X-ray imaging system designed for radiologic procedures. It generates high-quality radiographic images for diagnostic evaluation in clinical settings, supporting a range of medical specialties within radiology. The device operates as part of a fixed imaging system, enabling precise visualization of internal structures for conditions requiring radiographic assessment.
This system is supplied as a reusable medical device and is intended for use in radiology departments or imaging centers. It is classified as a Class 2 device under FDA regulations (product code KPR) and has received FDA 510(k) clearance through the Traditional pathway. The device is not specified as MRI-safe or single-use, and its operational specifications align with stationary X-ray imaging standards. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and compliance with regulatory requirements.
Questions
AI-generated answers, 1 Oct 2026
What is the DFP4343C7 used for?
The DFP4343C7 is a stationary X-ray imaging system designed specifically for generating high-quality radiographic images in clinical settings. It supports diagnostic evaluations across various medical specialties within radiology, enabling precise visualization of internal structures for conditions requiring radiographic assessment. This makes it ideal for routine and specialized imaging procedures in radiology departments or imaging centers.
Is the DFP4343C7 single-use or reusable?
The DFP4343C7 is supplied as a reusable medical device. Unlike single-use devices, it is intended for repeated use in radiology departments, provided it undergoes proper maintenance and cleaning as outlined by the manufacturer’s guidelines. This ensures compliance with regulatory requirements and sustained functionality over time.
What regulatory pathway was followed for the DFP4343C7?
The DFP4343C7 received FDA 510(k) clearance through the Traditional pathway, demonstrating that it is substantially equivalent to a legally marketed device. This clearance confirms its compliance with FDA regulations and its classification as a Class 2 medical device under product code KPR. The device’s regulatory status ensures it meets established safety and performance standards.
How should the DFP4343C7 be stored and maintained?
Storage and maintenance of the DFP4343C7 must adhere to the manufacturer’s guidelines to preserve functionality and ensure compliance. These guidelines typically include environmental controls (e.g., temperature, humidity), regular calibration checks, and scheduled servicing to prevent equipment degradation. Proper maintenance is critical for consistent image quality and operational reliability in clinical settings.
Does the DFP4343C7 have any specific safety considerations, such as MRI compatibility?
The DFP4343C7 is not specified as MRI-safe in the provided documentation. This means it should not be used in proximity to MRI environments unless explicitly verified by the manufacturer for compatibility. Clinicians should consult the manufacturer’s instructions to ensure safe integration with other imaging modalities and avoid potential interference or hazards.