MAGNETOM Skyra Fit
K220589Siemens Medical Solutions USA, Inc. · cleared 2022-05-13 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Your 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 the internal structure and/or function of the head, body, or extremities.”
source quote (p.6)
“TSE MoCo: TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type. Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection. Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.”
Validation studies (3)
Bench
sample size not stated
endpoints: image quality / quantitative data
Bench
sample size not stated
Bench
sample size not stated
standards: AAMI / ANSI ES60601-1, IEC 60601-2-33
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232494 (decision 2023-11-14) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Avanto fit; MAGNETOM Skyra fit") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232494
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K231560 (decision 2023-10-23) from Siemens Medical Solutions USA, Inc. for a matching device line ("MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231560
- 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).