SIGNA 7.0T

K201615

GE Medical Systems, LLC · cleared 2020-10-15 · product code LNH · Radiology

FDA 510(k) summary for SIGNA 7.0T (K201615)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
2
Cited predicates
1
Performance observations
0
Product code
LNH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware
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.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

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

Reader study (MRMC)

sample size not stated

endpoints: image diagnostic quality; usability; personal preferences; general commentary using radiology terms

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

25
recalls in product code, 24mo
530
MAUDE reports in code, 12mo
+6%
vs code's own 3-yr baseline
9
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K201615