SIGNA 7.0T
K201615GE Medical Systems, LLC · cleared 2020-10-15 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The SIGNA 7.0T 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 head and extremities.”
source quote (p.5)
“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. Applications: The SIGNA 7.0T uses the SIGNA Works suite of applications, optimized for the advanced hardware and for the higher field strength to generate high resolution functional, structural, anatomical, vascular, and spectroscopic images.”
Validation studies (3)
Bench
sample size not stated
standards: ANSI/AAMI ES60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI/IEC 62304, AAMI/ANSI/ISO 10993-1, NEMA MS standards for MRI, NEMA PS3 standards for DICOM
Reader study (MRMC)
sample size not stated
endpoints: evaluating proposed device's image diagnostic quality and usability; personal preferences; general commentary using radiology terms against same subject images scanned on the predicate device
Prospective clinical
sample size not stated
endpoints: set the PNS limits
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 3 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).