Digital X-Ray Imaging System, Model: CXD-DR80D
510(k) K083640
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083640 | Date29 Jun 2009 | 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- Withdrawn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
- 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, 19 Sep 2026
A Digital X-Ray Imaging System, Model: CXD-DR80D is a stationary digital X-ray imaging system used in hospitals for generating radiographic images of human anatomy. It is indicated for skeletal, respiratory, and urinary system diagnostics.
The system includes components such as a high-frequency inverter HV generator, tube support, X-ray beam limiter, wall stand, bucky table, and FLAATZ 750 detector. Operation involves setting tube voltage, current, and time; X-rays pass through the patient to the detector for image capture. It is supplied as a reusable system and has received FDA 510(k) clearance under K083640, with product code KPR and device class 2.
Other devices from Choong Wae Medical Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the Digital X-Ray Imaging System, Model: CXD-DR80D used for?
The system is used in hospitals to generate radiographic images of human anatomy for diagnostic purposes, specifically indicated for skeletal, respiratory, and urinary system imaging, based on its intended use as a stationary digital X-ray imaging system.
How is the Digital X-Ray Imaging System, Model: CXD-DR80D supplied and is it reusable?
The system is supplied as a reusable system, meaning it is designed for repeated use after appropriate cleaning and maintenance, and is not intended for single-use disposal.
What regulatory pathway was used for the Digital X-Ray Imaging System, Model: CXD-DR80D?
The device received FDA 510(k) clearance under submission number K083640, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) process.
What components are included in the Digital X-Ray Imaging System, Model: CXD-DR80D?
The system includes a high-frequency inverter HV generator, tube support, X-ray beam limiter, wall stand, bucky table, and FLAATZ 750 detector, which work together to produce radiographic images after setting tube voltage, current, and exposure time.
What is the product code and device class for the Digital X-Ray Imaging System, Model: CXD-DR80D?
The device has product code KPR and is classified as Class II under FDA regulations, as indicated in the 510(k) clearance documentation and openFDA data.