Class Class II
3.0T 16ch AIR AA (K223378)
Description
3.0T 16ch AIR AA by Ge Healthcare Coils (Usa Instruments, Inc.), an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223378
Clearance Date2023-01-03
Clearance TypeAbbreviated
Product CodeMOS
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223378
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. 3.0T 16ch AIR AA (K223378) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch A... | GE Healthcare | 2018 |
Trace the full predicate network for K223378
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.