SIGNA™ Sprint Select

K253779

Ge Medical Systems, LLC · cleared 2026-02-05 · product code LNH · Radiology

FDA 510(k) summary for SIGNA™ Sprint Select (K253779)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
3
Performance observations
0
Product code
LNH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.4)
“The SIGNA™ Sprint Select is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.”
AlgorithmAI-powered workflow for patient setup and automatic landmarking, and AI features for image reconstruction (AIR Recon DL, Sonic DL, AIRx).
source quote (p.6)
“A platform software with various PSD and applications, including the following Al features: AIR™ Recon DL (Cleared in K213717). Sonic DLT™ (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 Al-powered workflow that enables fast patient setup and automatic landmarking using a live camera feed.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

standards: ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION, 60601-2-33 Edition 4.0 2022-08, 60601-1-2: 2014 [Including AMD 1:2021], 62304: 2006/A1:2016, 10993-1: 2018, 62464-1 Edition 2.0 2018-12, MS-1-2008 (R2020), MS 2-2008 (R2020), MS 3-2008 (R2020), MS 4-2023, MS 5-2018, MS 8-2016 (R2003), 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

25
recalls in product code, 24mo
530
MAUDE reports in code, 12mo
+6%
vs code's own 3-yr baseline
2
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code LNH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

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Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253779