FDA.reportPublic FDA data

MinXray

Primary DI
00858846007222
Brand
MinXray
Company
MINXRAY, INC.
Model
CMDR.TW.1202.R
Device description
This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes.
Published
2017-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile
LLZSystem, Image Processing, Radiological
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171353000CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisMinxray, Inc.2017-06-07IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858846007222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858846007222008588460072228588460072220858846007222

GMDN Terms#

Term, Definition table
TermDefinition
Portable basic diagnostic x-ray system, analogueAn assembly of devices that comprise a general-purpose portable analogue diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that uses analogue or analogue-to-digital techniques for image capture and display. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and 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 Pressure700 millibar1060 millibar
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-221-2245service@minxray.com

Regulatory Flags#

DUNS number
042071001
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858846007253MinXrayTR90BH2019-01-14
00858846007000MinXrayHF1202H Portable X-ray2017-08-04
00858846007017MinXrayHF100H+ Portable X-ray2017-08-04
00858846007024MinXrayHF120/60HPPWV PowerPlus Portable X-ray2017-08-04
00858846007031MinXrayCMDR-2SLWT2017-08-04
00858846007048MinXrayCMDR.T.120.60.R2017-08-04
00858846007055MinXrayCMDR.T.120.60.S2017-08-04
00858846007062MinXrayCMDR.PE.100.S2017-08-04
00858846007079MinXrayCMDR.PE.1202.R2017-08-04
00858846007086MinXrayCMDR.T.100.R2017-08-04
00858846007093MinXrayCMDR.TW.100.S2017-08-04
00858846007109MinXrayCMDR.T.1202.S2017-08-04
00858846007116MinXrayCMDR.T.1202.R2017-08-04
00858846007123MinXrayCMDR.TW.1202.S2017-08-04
00858846007130MinXrayCMDR.TW.100.R2017-08-04
00858846007147MinXrayCMDR.T.100.S2017-08-04
00858846007154MinXrayCMDR.TW.120.60.S2017-08-04
00858846007161MinXrayCMDR.PE.120.60.R2017-08-04
00858846007178MinXrayIntegris2017-08-04
00858846007185MinXrayCMDR.PE.100.R2017-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
00850079606081MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-09-21
00850079606098EmitterOXOS Medical, Inc.IZL2026-09-21
00850079606104CassetteOXOS Medical, Inc.IZL2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
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00817886020578JointsMEDSTRAT, INC.LLZ2024-04-12
00817886020561JointsMEDSTRAT, INC.LLZ2024-02-10
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