uMR

GUDID 00810030350057

The uMR 570 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.

UIH TECHNOLOGIES LLC

Full-body MRI system, superconducting magnet

• Primary Device ID: 00810030350057
• NIH Device Record Key: 1c35877d-753c-405c-9562-df043d3bfcda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uMR
• Version Model Number: uMR 570
• Company DUNS: 117116896
• Company Name: UIH TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810030350057 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-11
• Device Publish Date: 2020-05-01

Devices Manufactured by UIH TECHNOLOGIES LLC

• 00810030350095 - uMI VM: 2021-11-29 The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is int
• 00810030350088 - uMI: 2021-06-14 The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is int
• 00810030350019 - uCT: 2020-12-28 The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional image
• 00810030350026 - uCT: 2020-12-28 The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional image
• 00810030350040 - uCT: 2020-05-21 The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional image
• 00810030350033 - uCT: 2020-05-11 The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional image
• 00810030350057 - uMR: 2020-05-11The uMR 570 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.
• 00810030350057 - uMR: 2020-05-11 The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, cor
• 00810030350002 - uDR: 2020-05-07 The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric