SIGNA Sprint
K251399GE Medical Systems, LLC · cleared 2025-09-11 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“A platform software with various PSD and applications, including the following AI features: AIRx™ (Cleared in K183231) AIR™ Recon DL (Cleared in K202238) Sonic DLT™ (Cleared in K223523)”
source quote (p.6)
“A platform software with various PSD and applications, including the following AI features: AIRx™ (Cleared in K183231) AIR™ Recon DL (Cleared in K202238) Sonic DLT™ (Cleared in K223523)”
Validation studies (2)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, NEMA MS 1, NEMA MS 2, NEMA MS 3, NEMA MS 4, NEMA MS 5, NEMA MS 8, NEMA MS 9, NEMA MS 14, NEMA PS 3.1 – 3.20
Retrospective clinical
sample size not stated
endpoints: acceptable diagnostic image performance; image quality performance
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) K253779 (decision 2026-02-05) from Ge Medical Systems, LLC for a matching device line ("SIGNA Sprint Select") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253779
- 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).