uMR 680
K252371Shanghai United Imaging Healthcare Co., Ltd. · cleared 2025-09-25 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The uMR 680 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc.”
source quote (p.12)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
Validation studies (7)
Bench
sample size not stated
endpoints: Materials of construction and manufacturing materials do not introduce chemicals that raise a biocompatibility concern.
standards: ISO 10993-5: 2009, Edition 3.0, ISO 10993-10: 2021, Edition 4.0, ISO 10993-23: 2021, Edition 1.0, ISO 10993-1
Bench
sample size not stated
endpoints: Conform with IEC 60601-1-2 and IEC 60601-4-2.
standards: IEC 60601-1-2, IEC 60601-4-2
Bench
sample size not stated
endpoints: SNR and Uniformity shall fulfill with the design specification.
standards: NEMA MS 1, NEMA MS 3, NEMA MS 6, NEMA MS 9
Bench
sample size not stated
endpoints: The maximum temperature of all temperature probes shall not exceed 41°C.
standards: NEMA MS 14
Reader study (MRMC)
sample size not stated
endpoints: Image quality is sufficient for diagnostic use.
Bench
sample size not stated
endpoints: Conform with ANSI/AAMI ES60601-1.
standards: ANSI/AAMI ES60601-1
Bench
sample size not stated
endpoints: Conform with IEC 60601-2-33.
standards: IEC 60601-2-33, NEMA MS 8
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
- 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).