uMR 680
K222755Shanghai United Imaging Intelligence Co., Ltd. · cleared 2023-02-16 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“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. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. DeepRecon is a deep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution.”
source quote (p.12)
“DeepRecon is a deep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution.”
Validation studies (1)
Retrospective clinical
n=68 patients
endpoints: Image SNR; Image Uniformity; Image Resolution; Image Contrast; Structure Measurement
standards: ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 4.0 2014-02, 60601-2-33 Ed. 3.2:2015, IEC 60825-1 Edition 2.0 2007-03, ISO 10993-5 Third Edition 2009-06-01, ISO 10993-10 Third Edition 2010-08-01, IEC 62464-1 Edition 2.0: 2018-12, MS 1-2008(R2020), MS 2-2008(R2020), MS 3-2008(R2020), MS 4-2010, MS 5-2018, MS 6-2008(R2014), MS 8-2016, MS 9-2008(R2020), MS 14-2019
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).