FDA.reportPublic FDA data

Interventional Fluoroscopic Mobile X-ray System

Primary DI
08809246620049
Brand
Interventional Fluoroscopic Mobile X-ray System
Company
GEMSS MEDICAL SYSTEMS CO.,LTD.
Model
SPINEL 12HD
Catalog number
SPINEL 12HD
Device description
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.
Published
2018-02-05
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
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163140000SPINEL 12HD Interventional Fluoroscopic Mobile X-ray SystemGemss Medical Systems Co., Ltd.2017-05-26OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809246620049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809246620049088092466200498809246620049

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
+82317462211sangwoo.lee@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
08809246620025Image-intensified fluoroscopic x-ray system, mobileKMC-650KMC-6502016-09-24

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Primary DI, Brand, Company table
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