Class Class II
InVision™ 3T Recharge Operating Suite (K252239)
Description
InVision™ 3T Recharge Operating Suite by Imris Imaging, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252239
Clearance Date2025-08-06
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252239
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. InVision™ 3T Recharge Operating Suite (K252239) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212367 | IMRIS iMRI 3T V | Deerfield Imaging, Inc. | 2021 |
| K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | 2020 |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | Imris, Inc. | 2011 |
Trace the full predicate network for K252239
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.