Class Class II
1.5T 24E Posterior Array (K223203)
Description
1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223203
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223203
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. 1.5T 24E Posterior Array (K223203) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K123417 | BRIVO MR355, OPTIMA MR360 | Ge Hangwei Medical Systems Co., Ltd. | 2013 |
Trace the full predicate network for K223203
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.