Class Class II
Spectral CT (K244008)
Description
Spectral CT by Philips Medical Systems Technologies , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244008
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeJAK
Regulation Number892.1750
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244008
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. Spectral CT (K244008) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240844 | Spectral CT 7500 RT | Philips Medical Systems Technologie... | 2024 |
| K203020 | Spectral CT | Philips Medical Systems Nederland B.V. | 2021 |
Trace the full predicate network for K244008
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.