Radiology · 510(k) · 2024
uMR 680
Shanghai United Imaging Healthcare Co., Ltd.. Cleared by FDA on 10 April 2024 under submission K240744, product code LNH (system, nuclear magnetic resonance imaging). What FDA's record says, in FDA's words.
Device record · K240744
- Device. uMR 680DEVICE
- Company. Shanghai United Imaging Healthcare Co., Ltd. (CN)COMPANY
- Decision. 10 April 2024, 510(k), substantially equivalent (special review); received 18 March 2024DECISION
- Panel. RadiologyPANEL
- Product code. LNH, System, Nuclear Magnetic Resonance ImagingCODE
- Regulation. 21 CFR 892.1000, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedMRI
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,787 reports filed against devices carrying product code LNH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
29 September 2026 · Malfunction · Achieva 1.5T Dstream · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000174
28 September 2026 · Malfunction · Achieva 1.5T · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000166
Philips received a report that the Quadrature Body Coil (QBC) seal on the front cover is coming loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose, it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000167
Philips received a report that the upper Quadrature Body Coil (QBC) seal has peeling off. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is peeled it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000168
Philips received a report that the Quadrature Body Coil (QBC) seal has come loose. This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal comes loose it is likely that this could lead to serious injury.
28 September 2026 · Malfunction · Ingenia · Philips Medical Systems Nederland B.V. · report 3042177665-2026-000169
Philips received a report that the upper Quadrature Body Coil (QBC) seal has come loose This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the Magnet covers.If this seal is loose it is likely that this could lead to serious injury.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LNH, in Radiology, from Shanghai United Imaging Healthcare Co., Ltd., or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.