UIH TECHNOLOGIES, LLC

FDA Device Registration & Listing · Houston, TX, US · Registration 3014809646

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014809646
FEI Number
3014809646
Entity Name
UIH TECHNOLOGIES, LLC
City/State/Country
Houston, TX, US
Establishment Address
9380 Kirby Drive, Houston, TX 77054, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
UIH Technologies LLC (Owner Number: 10059270)
Owner / Operator Contact Address
9380 Kirby Drive, Houston, TX 77054, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

uMI 550 uDR 380i Pro uMR 680 uCT 760, uCT 780 uMR Omega uCT 780 uCT 760 uMR Omega uCT ATLAS Astound uCT 530/550 uCT 780 uMR 680 uMI 550

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-01-14
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-01-14
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2025-08-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-08-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-12-18
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2020-12-18
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2024-02-29
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-09-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-08-01
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-08-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-08-01
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-12-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-09-18
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-12-02
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-08-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-08-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-08-01
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-08-01
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-08-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-04-23
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-08-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-08-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-08-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-12-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-12-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-04-23
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-05-06
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-08-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-08-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-12-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-12-02
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-12-18
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2020-12-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-03-27

Official Correspondent

Jun Zhu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UIH Technologies LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014809646. Last updated year: 2026. Please use registration number 3014809646 when referencing this establishment in official correspondence.
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