SIGNA Sprint Select
K253779Ge Medical Systems, LLC · cleared 2026-02-05 · 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: • AIR™ Recon DL (Cleared in K213717). • Sonic DL™ (Cleared in K243667). • AIRx™ (Cleared in K183231). The AIRx™ has been modified to include spine and prostate anatomical regions, in addition to its existing functionality for brain and knee. • SIGNA One Camera: An AI-powered workflow that enables fast patient setup and automatic landmarking using a live camera feed.”
source quote (p.6)
“SIGNA One Camera: An AI-powered workflow that enables fast patient setup and automatic landmarking using a live camera feed.”
Validation studies (2)
Bench
sample size not stated
standards: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, IEC 60601-2-33 Edition 4.0 2022-08, ANSI AAMI IEC 60601-1-2: 2014 [Including AMD 1:2021], ANSI AAMI IEC 62304: 2006/A1:2016, ANSI AAMI ISO 10993-1: 2018, IEC 62464-1 Edition 2.0 2018-12, NEMA MS-1-2008 (R2020), NEMA MS 2-2008 (R2020), NEMA MS 3-2008 (R2020), NEMA MS 4-2023, NEMA MS 5-2018, NEMA MS 8-2016 (R2003), NEMA PS 3.1 - 3.20 2023e
Reader study (MRMC)
sample size not stated
endpoints: sufficient quality for diagnostic use
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).