Wireless/ Wired X-Ray Flat Panel Detectors
FDA 510(k) K243734 · Allengers Medical Systems Limited
510(k) numberK243734
Submission
- Device name
- Wireless/ Wired X-Ray Flat Panel Detectors
- Applicant
- Allengers Medical Systems Limited
Sas Nagar Mohali, IN - Received
- December 4, 2024
- Decision date
- April 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K252911 | Lux HD 2530 detector (Lux HD 2530)MQB · Special | Iray Imaging Technology (Haining) Limited | 10/09/2025SE |
| K250211 | Yushan X-Ray Flat Panel DetectorMQB · Traditional | Innocare Optoelectronics Corp. | 07/22/2025SE |
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| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)MQB · Traditional | Iray Imaging Technology (Haining) Limited | 03/18/2025SE |
| K244010 | ExamVue ApexMQB · Traditional | Jpi Healthcare Co, Ltd. | 02/24/2025SE |
More from Jpi Healthcare Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253296 | Digital C-ARM with 3DOXO · Traditional | 06/05/2026SE |
| K223009 | Wireless/Wired X-Ray Flat Panel DetectorsMQB · Traditional | 11/27/2022SE |
| K223060 | DigiX FDXKPR · Special | 10/26/2022SE |
| K220311 | Cardiovascular Angiography SystemOWB · Traditional | 05/03/2022SE |
| K200218 | Digiscan FDXOWB · Traditional | 07/13/2020SE |
| K192541 | DigiX FDXKPR · Special | 10/16/2019SE |
| K162529 | DigiX FDXKPR · Traditional | 03/03/2017SE |
Questions and answers
When was Wireless/ Wired X-Ray Flat Panel Detectors cleared by the FDA?
Wireless/ Wired X-Ray Flat Panel Detectors (K243734) received a 510(k) decision of Substantially Equivalent on April 18, 2025, 135 days after the submission was received.
What is the product code of K243734?
The FDA product code is MQB – Solid State X-Ray Imager (Flat Panel/Digital Imager), a Class II (moderate risk) device regulated under 21 CFR 892.1680.