SIGNA 7.0T
K211118GE Medical Systems, LLC · cleared 2021-05-13 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“SIGNA 7.0T is a high performance magnetic resonance imaging system designed to support high resolution imaging at 7.0T in particular anatomical regions determined by the available RF coils. The system includes a 7.0T superconducting magnet and an ultra-high performance gradient coil with a 60 cm patient bore, supporting scanning in axial, coronal, sagittal, oblique, and double oblique planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms. ... The software used on the proposed SIGNA 7.0T system has been modified to include the AIR Recon DL feature.”
source quote (p.5)
“The software used on the proposed SIGNA 7.0T 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
Retrospective clinical
sample size not stated
endpoints: SNR; image sharpness
Reader study (MRMC)
sample size not stated
endpoints: SNR; sharpness; radiologist preference for clinical evaluation
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) K253780 (decision 2026-02-06) from Ge Medical Systems, LLC for a matching device line ("SIGNA Bolt") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253780
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253779 (decision 2026-02-05) from Ge Medical Systems, LLC for a matching device line ("SIGNA Sprint Select") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253779
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251399 (decision 2025-09-11) from GE Medical Systems, LLC for a matching device line ("SIGNA Sprint") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251399
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250379 (decision 2025-03-17) from GE Medical Systems, LLC for a matching device line ("SIGNA Prime Elite") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250379
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K241242 (decision 2024-10-17) from GE Medical Systems, LLC for a matching device line ("SIGNA MAGNUS") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241242
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K213668 (decision 2022-01-20) from GE Healthcare (GE Medical Systems, LLC) for a matching device line ("SIGNA Hero") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213668
- …and 2 more.
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).