GEMSS MEDICAL SYSTEMS CO.,LTD.

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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

Image-Intensified Fluoroscopic X-Ray System, Mobile (OXO) (4) System, X-Ray, Fluoroscopic, Image-Intensified (JAA) (4) Interventional Fluoroscopic X-Ray System (OWB) (2) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

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SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED - 08809246620001 Catalog Number : KMC-950

Device Description : The KMC-950 is a great solution to produce radiological images of patient during The KMC-950 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Class : 2

Duns Number: 689163897

Premarket Exempt : No

Product Code : OXO, JAA, OWB

Prescription Use : No

Device Count : 1

IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE - 08809246620018 Catalog Number : SPINEL 3G

Device Description : The SPINEL 3G is a great solution to produce radiological images of patient duri The SPINEL 3G is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Class : 2

Duns Number: 689163897

Premarket Exempt : No

Product Code : JAA, OXO

Prescription Use : No

Device Count : 1

Image-intensified fluoroscopic x-ray system, mobile - 08809246620025 Catalog Number : KMC-650

Device Description : The KMC-650 is a great solution to produce radiological images of patient during The KMC-650 is a great solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Class : 2

Duns Number: 689163897

Premarket Exempt : No

Product Code : JAA, OXO

Prescription Use : No

Device Count : 1

SYSTEM, X-RAY, STATIONARY - 08809246620032 Catalog Number : TITAN 11

Device Description : TITAN 11 is a diagnostic DR System that contains high output capacity and high-r TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.

Device Class : 2

Duns Number: 689163897

Premarket Exempt : No

Product Code : KPR

Prescription Use : No

Device Count : 1

Interventional Fluoroscopic Mobile X-ray System - 08809246620049 Catalog Number : SPINEL 12HD

Device Description : SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide flu SPINEL 12HD Surgical Mobile Fluoroscopic X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

Device Class : 2

Duns Number: 689163897

Premarket Exempt : No

Product Code : JAA, OXO, OWB

Prescription Use : No

Device Count : 1

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