uMR Jupiter

K233673

Shanghai United Imaging Healthcare Co., Ltd · cleared 2024-04-26 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.5)
“uMR Jupiter is a 5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore and 8 channel RF transmit system.”
AlgorithmACS is an acceleration reconstruction technique. By adding one more regularization term from Al module, ACS is a slight extension of CS (Compressed Sensing).
source quote (p.12)
“ACS is an acceleration reconstruction technique. By adding one more regularization term from Al module, ACS is a slight extension of CS (Compressed Sensing).”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.11)
“Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”

Validation studies (5)

Bench

sample size not stated

endpoints: image performance tests; design specifications

standards: ANSI/AAMIES60601-1: 2005/ (R) 2012+A1:2012+C1:2009/(R)2012+A2:2010/(R)2012) [IncludingAmendment2(2021)]Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2014+A1:200, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests, IEC 60601-2-33 Ed. 3.2:2015 Medical Electrical Equipment - Part 2-33: Particular Requirements for The Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnostic, IEC 60825-1: 2014, Edition 3.0, Safety of laser products - Part 1: Equipment classification and requirements., IEC 60601-1-6:2010+A1:2013+A2:2020, Edition 3.2, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability., IEC 62304:2006+AMD1:2015 CSV Consolidated version, Medical device software - Software life cycle processes, IEC 62464-1 Edition 2.0: 2018-12, Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters., NEMA MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images, NEMA MS 2-2008(R2020), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images, NEMA MS 3-2008(R2020), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images, NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices, NEMA MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging, NEMA MS 6-2008(R2014, R2020), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging, NEMA MS 8-2016, Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems, NEMA MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images, NEMA MS 10-2010, Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging., NEMA MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems, IEC /TR 60601-4-2: 2016, Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems, NEMA PS 3.1-3.20(2022d): Digital Imaging and Communications in Medicine (DICOM), 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, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity., ISO 10993-10: 2021, Edition 4.0, Biological evaluation of medical devices - Part 10: Tests for skin sensitization., ISO 10993-23: 2021, Edition 1.0, Biological evaluation of medical devices - Part 10: Tests for irritation., Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", ISO 14971: 2019, Edition 3.0, Medical Devices – Application of risk management to medical devices, Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation, Code of Federal Regulations, Title 21, Subchapter J - Radiological Health

Prospective clinical

sample size not stated

endpoints: determine the nerve stimulation thresholds; set the PNS (Peripheral Nerve Stimulation) threshold level

standards: IEC 60601-2-33

Reader study (MRMC)

sample size not stated

endpoints: generate diagnostic quality images

Retrospective clinical

n=25 patients

endpoints: perform better than CS by measuring SNR and resolution; maintained image qualities, such as contrast and uniformity; performs equivalently to that on uMR Omega; structure measurements on paired images verified that ACS and fully sampled images of same structures were significantly the same

Bench

sample size not stated

endpoints: verify its performance

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
5
drift signals on this device
  • 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) 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

  • 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/K233673