uMR 680

K252371

Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-09-25 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.6)
“The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (2)

Bench

sample size not stated

endpoints: met all design specifications; Substantially Equivalent (SE) to the predicate device

standards: ISO 10993-1, IEC 60601-1-2, IEC 60601-4-2, NEMA MS 1, NEMA MS 3, NEMA MS 6, NEMA MS 9, NEMA MS 14, ANSI/AAMI ES60601-1, IEC 60601-2-33, NEMA MS 8, IEC 62304:2006+AMD1:2015 CSV Consolidated version, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, ISO 10993-5: 2009, Edition 3.0, ISO 10993-10: 2021, Edition 4.0, ISO 10993-23: 2021, Edition 1.0, ISO 14971: 2019, Edition 3.0, Code of Federal Regulations, Title 21, Part 820, Code of Federal Regulations, Title 21, Subchapter J

Reader study (MRMC)

sample size not stated

endpoints: diagnostic quality images

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

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); 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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252371