MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
K260265Siemens Shenzhen Magnetic Resonance , Ltd. · cleared 2026-02-23 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that displays, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body, or extremities.”
Validation studies (1)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1:2005, IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-2-33 Edition 4.0 2022-08, ISO 14971 Third edition 2019-12, ANSI AAMI IEC 62366-1: 2015 + AMD1:2020, IEC 62304:2006 + AMD1:2015, NEMA MS 4-2010, NEMA MS 9-2008 (R2020), NEMA PS 3.1 - 3.20 (2023e), ANSI AAMI ISO 10993-1: 2018
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- predicate_cohort_contagion
K260265 shares predicate K250436 with K253023 (BIOGRAPH One), whose product code OUO recorded 1 recall event(s) in the trailing 24 months.
first seen 2026-07-08 · predicate:K250436 sibling:K253023
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).