FDA.reportPublic FDA data

Image-intensified fluoroscopic x-ray system, mobile

Primary DI
08809246620025
Brand
Image-intensified fluoroscopic x-ray system, mobile
Company
GEMSS MEDICAL SYSTEMS CO.,LTD.
Model
KMC-650
Catalog number
KMC-650
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160065000GEMSS Medical System Surgical Mobile Fluoroscopic X-ray SystemGemss Medical Systems Co., Ltd.2016-05-20OXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809246620025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809246620025088092466200258809246620025

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82317372211sangwoo@gemss-medical.com

Regulatory Flags#

DUNS number
689163897
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809246620032SYSTEM, X-RAY, STATIONARYTITAN 11TITAN 112016-09-24
08809246620001SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIEDKMC-950KMC-9502016-09-24
08809246620018 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILESPINEL 3GSPINEL 3G2016-09-24
08809246620049Interventional Fluoroscopic Mobile X-ray SystemSPINEL 12HDSPINEL 12HD2018-02-05

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Primary DI, Brand, Company table
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