Class Class II
Digital Flat Panel Detector (K230059)
Description
Digital Flat Panel Detector by Ray Imaging Technology (Haining) Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230059
Clearance Date2023-02-03
Clearance TypeSpecial
Product CodeMQB
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230059
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. Digital Flat Panel Detector (K230059) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233381 | DRX-Evolution Plus System | Carestream Health, Inc. | 2024 |
Trace the full predicate network for K230059
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.