UIH TECHNOLOGIES LLC

Address:9380 Kirby Drive,Houston,TX,77054,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, X-Ray, Tomography, Computed (JAK) (6) System, Tomography, Computed, Emission (KPS) (2) System, X-Ray, Stationary (KPR) (2) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1) System, Nuclear Magnetic Resonance Imaging (LNH) (1)

Premarket Exempt

Clear

uDR - 00810030350002 Catalog Number :

Device Description : The uDR 596i Radiographic system is intended to be used by a qualified/trained d The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : MQB, KPR

Prescription Use : Yes

Device Count : 1

uCT - 00810030350019 Catalog Number :

Device Description : The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

uCT - 00810030350026 Catalog Number :

Device Description : The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

uCT - 00810030350033 Catalog Number :

Device Description : The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

uCT - 00810030350040 Catalog Number :

Device Description : The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

uMR - 00810030350057 Catalog Number :

Device Description : The uMR 570 system is indicated for use as a magnetic resonance diagnostic devic 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.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

uDR - 00810030350071 Catalog Number :

Device Description : The uDR 780i digital medical x-ray system is intended for use by a qualified/tra The uDR 780i digital medical x-ray system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other anatomic sites. Applications can be performed with the subject sitting, standing, or lying in the prone or supine position. Not for mammography.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

uMI - 00810030350088 Catalog Number :

Device Description : The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : KPS, JAK

Prescription Use : Yes

Device Count : 1

uMI VM - 00810030350095 Catalog Number :

Device Class : 2

Duns Number: 117116896

Premarket Exempt : No

Product Code : KPS, JAK

Prescription Use : Yes

Device Count : 1

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