Class Class II
8ch T/R Knee Coil (K223225)
Description
8ch T/R Knee Coil by Shenzhen RF Tech Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223225
Clearance Date2023-02-14
Clearance TypeTraditional
Product CodeMOS
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223225
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. 8ch T/R Knee Coil (K223225) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K032633 | HRK-63-8 KNEE ARRAY COIL | Mri Devices Corp. | 2003 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | 2023 |
Trace the full predicate network for K223225
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.