SIGNA Artist
K202238GE Healthcare (Tianjin) Company Limited · cleared 2020-09-04 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Artist system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. This 510(k) submission is for the SIGNA Artist 1.5T MR system, and has been triggered by the addition of the AIR Recon DL software feature.”
source quote (p.5)
“This 510(k) submission is for the SIGNA Artist 1.5T MR system, and has been triggered by the addition of the AIR Recon DL software feature. The software used on the proposed SIGNA Artist system has been modified to include the AIR Recon DL feature. The User interface provides operators of the system with new options for selecting AIR Recon DL and adjusting the associated level of image noise reduction. The resulting images can have higher SNR and improved sharpness compared to images reconstructed without AIR Recon DL.”
Validation studies (3)
Bench
sample size not stated
endpoints: image quality; SNR; sharpness; low contrast detectability; noise spectral content; quantitative measurements based on signal intensity; influence of motion during image acquisition
Retrospective clinical
sample size not stated
endpoints: SNR; image sharpness; image quality; lesion conspicuity
Reader study (MRMC)
sample size not stated
endpoints: image quality; lesion conspicuity; radiologist preference
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).