Class Class II
dS Wrist coil 8ch 1.5T (K243033)
Description
dS Wrist coil 8ch 1.5T by Philips Medical Systems Nederland B.V., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243033
Clearance Date2024-10-18
Clearance TypeSpecial
Product CodeMOS
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243033
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. dS Wrist coil 8ch 1.5T (K243033) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade ... | 2022 |
Trace the full predicate network for K243033
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.