SIGNA Premier
K193282GE Healthcare (GE Medical Systems, LLC) · cleared 2020-04-10 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“SIGNA Premier is a whole-body magnetic resonance scanner featuring a 3.0T superconducting magnet with a 70cm bore size. Major elements of the system include the magnet, gradient coils, body RF transmit coil, RF receive subsystem, patient support system (table), host computer, and system software. The system is compatible with a suite of RF receive coils, and is capable of using various pulse sequences, imaging techniques and reconstruction algorithms. This submission is prompted by the introduction of a new software feature called AIR Recon DL onto the SIGNA Premier system. AIR Recon DL is a deep-learning based reconstruction technique designed to improve signal-to-noise ratio (SNR) and image sharpness.”
source quote (p.4)
“AIR Recon DL is a deep-learning based reconstruction technique designed to improve signal-to-noise ratio (SNR) and image sharpness.”
Validation studies (2)
Bench
sample size not stated
endpoints: evaluate the AIR Recon DL feature and its impact on image quality, including SNR, sharpness, low contrast detectability, and noise spectral content; confirm that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity; The influence of motion during image acquisition on the performance of AIR Recon DL was also evaluated
Reader study (MRMC)
sample size not stated
endpoints: confirm that the AIR Recon DL feature provides images with equivalent or better image quality in terms of the legibility of clinically relevant structures; the radiologists reading the images also indicated a preference for the AIR Recon DL images; lesion conspicuity is maintained with AIR Recon DL; the radiologists preferred the AIR Recon DL images for clinical 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
- 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
- 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).