Class Class II
DRX – Compass (K223842)
Description
DRX - Compass by Carestream Health, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223842
Clearance Date2023-01-20
Clearance TypeSpecial
Product CodeKPR
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223842
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. DRX – Compass (K223842) cites 8 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213529 | Focus HD 43 Detector | Iray Technology Taicang , Ltd. | 2022 |
| K213646 | Focus HD 35 Detector | Iray Technology Taicang , Ltd. | 2022 |
| K203159 | Lux 35 Detector | Carestream Health | 2020 |
| K201373 | DRX-Compass | Carestream Health, Inc. | 2020 |
| K200622 | Focus 43C detector, TRIMAX 43C detector | Iray Technology Taicang , Ltd. | 2020 |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. | 2019 |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. | 2019 |
| K150766 | Carestream DRX-1 System | Carestream Health, Inc. | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024 |
Trace the full predicate network for K223842
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.