Wireless Digital Flat Detector
by Iray Technology Taicang, Ltd.
510(k) K183713
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183713 | Date9 Jan 2019 | 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- Withdrawn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
- MQB
- FDA applicant
- Iray Technology Taicang , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Wireless Digital Flat Detector is a solid state X-ray imager designed to provide digital imaging solutions for general radiographic diagnosis of human anatomy. It functions as a digital flat panel detector used to capture X-ray images.
This device is regulated under FDA 510(k) clearance K183713. It is manufactured by Iray Technology Taicang, Ltd. and is intended for use in radiology applications.
Other devices from Iray Technology Taicang, Ltd.
Questions
AI-generated answers, 24 Sep 2026
What is the primary purpose of the Wireless Digital Flat Detector?
This device is a solid state X-ray imager designed to capture X-ray images for general radiographic diagnosis of human anatomy within radiology applications.
How is this device regulated?
The device is regulated under FDA 510(k) clearance number K183713, which confirms its status as a solid state X-ray imager for clinical use.
Who is the manufacturer of this digital flat panel detector?
The Wireless Digital Flat Detector is manufactured by Iray Technology Taicang, Ltd., located in the Taicang Port Economic and Technological Development Zone in China.