MAGNETOM Free.Max; MAGNETOM Free.Star
K231617Siemens Medical Solutions USA, Inc. · cleared 2023-11-09 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis. MAGNETOM Free.Max may also be used for imaging during interventional procedures when performed with MR-compatible devices such as MR Safe biopsy needles. Below Table 1 shows an executive summary of training and validation dataset of AI feature Deep Resolve Boost in subject devices:”
source quote (p.7)
“Below Table 1 shows an executive summary of training and validation dataset of AI feature Deep Resolve Boost in subject devices:”
Validation studies (1)
Retrospective clinical
n=26,473 images
endpoints: peak signal-to-noise ratio (PSNR); structural similarity index (SSIM); visual inspection for potential artefacts
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
- 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).