uMR 680
K240744Shanghai United Imaging Healthcare Co., Ltd. · cleared 2024-04-10 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.”
Validation studies (9)
Bench
sample size not stated
endpoints: Surface heating
standards: NEMA MS 14
Bench
sample size not stated
endpoints: General electrical/mechanical safety
standards: ANSI/AAMI ES60601-1
Bench
sample size not stated
endpoints: SNR and Uniformity
standards: NEMA MS 1, NEMA MS 3, NEMA MS 6, NEMA MS 9
Bench
sample size not stated
endpoints: Biocompatibility
standards: ISO 10993-1
Bench
sample size not stated
endpoints: EMC-immunity, electrostatic discharge
standards: IEC 60601-1-2, IEC 60601-4-2
Reader study (MRMC)
sample size not stated
endpoints: Image quality is sufficient for diagnostic use.
Bench
sample size not stated
endpoints: General electrical/mechanical safety
standards: ANSI/AAMI ES60601-1
Bench
sample size not stated
endpoints: EMC
standards: IEC 60601-1-2, IEC 60601-4-2
Bench
sample size not stated
endpoints: Bias of accuracy; Repeatability; Reproducibility; Parameter sensitivity
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252371 (decision 2025-09-25) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR 680") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252371
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250246 (decision 2025-08-05) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Jupiter") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250246
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243547 (decision 2025-07-17) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Ultra") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243547
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243397 (decision 2025-07-16) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR 680") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243397
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243122 (decision 2025-05-21) from Shanghai United Imaging Healthcare Co., Ltd. for a matching device line ("uMR Omega") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243122
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233673 (decision 2024-04-26) from Shanghai United Imaging Healthcare Co., Ltd for a matching device line ("uMR Jupiter") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233673
- …and 2 more.
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).