SIGNA Premier

K183231

GE Medical Systems, LLC · cleared 2019-01-18 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“The SIGNA Premier has been modified to include the AIRx feature, which automates and standardizes a number of connected steps required for an MRI examination of the brain. AIRx was developed using deep learning algorithms.”

Algorithmdeep learning algorithms

source quote (p.5)

“AIRx was developed using deep learning algorithms.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304, ANSI/AAMI 60601-1, IEC 60601-2-33

Retrospective clinical

sample size not stated

endpoints: productivity and consistency benefits

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K211118 (decision 2021-05-13) from GE Medical Systems, LLC for a matching device line ("SIGNA 7.0T") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211118
re_clearance
The FDA AI/ML device list shows a newer 510(k) K201615 (decision 2020-10-15) from GE Medical Systems, LLC for a matching device line ("SIGNA 7.0T") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K201615
re_clearance
The FDA AI/ML device list shows a newer 510(k) K193282 (decision 2020-04-10) from GE Healthcare (GE Medical Systems, LLC) for a matching device line ("SIGNA Premier") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K193282
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).