Class Class II
Wireless/ Wired X-Ray Flat Panel Detectors (K243734)
Description
Wireless/ Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243734
Clearance Date2025-04-18
Clearance TypeSpecial
Product CodeMQB
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243734
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Wireless/ Wired X-Ray Flat Panel Detectors (K243734) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2022 |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2022 |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2021 |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | 2020 |
Trace the full predicate network for K243734
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.