SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED - The KMC-950 is a great solution to produce - GEMSS MEDICAL SYSTEMS CO.,LTD.

Duns Number:689163897

Device Description: The KMC-950 is a great solution to produce radiological images of patient during medical o 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.

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More Product Details

Catalog Number

KMC-950

Brand Name

SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Version/Model Number

KMC-950

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K032761

Product Code Details

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

ee834460-6945-46b0-baad-791353a3c0fa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GEMSS MEDICAL SYSTEMS CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5