FDA.reportPublic FDA data

REMEX KA6

Primary DI
08800060100151
Brand
REMEX KA6
Company
REMEDI CO.,LTD.
Model
REMEX KA6
Published
2022-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZISystem, X-Ray, Angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212144000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212144000Remex KA6Remedi Co., Ltd.2021-08-03IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800060100151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800060100151088000601001518800060100151

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, digitalAn assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure76 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure76 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690072489
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800060100229REMEX Xcam6REMEX Xcam62026-01-22
08800060100205REMEX GR100REMEX GR1002025-04-18
08800060100243ENDURO DRES702024-09-20
08800060100236ENDORO DR ES70 X-ray SourceES702024-07-23
08800060100052Intraoral X-ray sensorIoDS-24012020-10-12
08800060100069Intraoral X-ray sensorIoDS-24022020-10-12
08800060100007MobileX Portable X-Ray SystemT-1002019-10-15
08800060100144REMEX T100REMEX T1002019-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
00860001790290SterimedSTERIMED LLCIZI2021-09-29
00860007655609SterimedSTERIMED LLCIZI2021-09-29
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
20193489066927NAMICMEDLINE INDUSTRIES, INC.IZI2021-05-12
00195278215543AlliaGE MEDICAL SYSTEMSIZI2021-03-31
00195278215550AlliaGE MEDICAL SYSTEMSIZI2021-03-31
10858701006213SPYNovadaq Technologies IncIZI2020-09-21
00860001790214SterimedSTERIMED LLCIZI2020-04-27
00810116023011Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00810116023028Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00840682147378INNOVAGE MEDICAL SYSTEMSIZI2020-02-03