Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“SIGNATM Bolt is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times, and is designed for improved patient comfort and workﬂow.”

AlgorithmAI-based automated slice prescription tool now extended with new deep learning models for spine and prostate imaging

source quote (p.6)

“AIRx (previously cleared in K183231) – AI-based automated slice prescription tool now extended with new deep learning models for spine and prostate imaging”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.8)

“Cybersecurity testing was completed and documented in accordance with the FDA guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” issued on June 27, 2025.”

Validation studies (4)

Standalone

n=80 patients

endpoints: landmark inference accuracy

standards: ANSI/AAMI/IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC TS 60601-4-2, IEC 62304, ISO 10993-1, IEC 62464-1, NEMA MS 1, NEMA MS 3, NEMA MS 4, NEMA MS 6, NEMA MS 8, NEMA MS 9, NEMA MS 14, NEMA PS 3.1 - 3.20

Reader study (MRMC)

n=11 other

endpoints: efficiency and reliability of the SIGNA One Camera landmarking workflow; setup times; landmark acceptance

standards: ANSI/AAMI/IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC TS 60601-4-2, IEC 62304, ISO 10993-1, IEC 62464-1, NEMA MS 1, NEMA MS 3, NEMA MS 4, NEMA MS 6, NEMA MS 8, NEMA MS 9, NEMA MS 14, NEMA PS 3.1 - 3.20

Standalone

n=376 patients

endpoints: scan prescription times; inter-operator variability; Structural Similarity Index (SSIM) analysis and visual comparisons

standards: ANSI/AAMI/IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC TS 60601-4-2, IEC 62304, ISO 10993-1, IEC 62464-1, NEMA MS 1, NEMA MS 3, NEMA MS 4, NEMA MS 6, NEMA MS 8, NEMA MS 9, NEMA MS 14, NEMA PS 3.1 - 3.20

Standalone

n=785 scans

endpoints: automated prostate scan plane prescription

standards: ANSI/AAMI/IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC TS 60601-4-2, IEC 62304, ISO 10993-1, IEC 62464-1, NEMA MS 1, NEMA MS 3, NEMA MS 4, NEMA MS 6, NEMA MS 8, NEMA MS 9, NEMA MS 14, NEMA PS 3.1 - 3.20

Reported performance (1 observation)

detection_rateas written: “successful detection rate”99

source quote (p.9)

“The SIGNA One Camera met the predeﬁned acceptance criterion of 90%, achieving successful detection in up to 99% of cases across all evaluated anatomical regions.”

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

2

drift signals on this device

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).