Class Class II
SKR 3000 (K250665)
Description
SKR 3000 by Konica Minolta, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250665
Clearance Date2025-06-17
Clearance TypeTraditional
Product CodeMQB
Regulation Number892.1680
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250665
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. SKR 3000 (K250665) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024 |
| K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | 2015 |
Trace the full predicate network for K250665
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.