Class Class II
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K250436)
Description
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus by Siemens Shenzhen Magnetic Resonance , Ltd., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250436
Clearance Date2025-06-16
Clearance TypeTraditional
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250436
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. MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K250436) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232535 | MAGNETOM Sola; MAGNETOM Altea | Siemens Medical Solutions USA, Inc. | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260265 | MAGNETOM Flow.Ace; MAGNETOM Flow.Plus | Siemens Shenzhen Magnetic Resonance... | 2026 |
Trace the full predicate network for K250436
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.