MinXray

Primary DI
00858846007253
Brand
MinXray
Company
MINXRAY, INC.
Model
TR90BH
Device description
The TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device may be used for stand mounted imaging of the chest when used without a grid. - Not to be used on bariatric patients, unless imaging body extremities - Not for mammography use - The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Published
2019-01-14
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182207000TR90BHMinxray, Inc.2018-12-14IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858846007253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858846007253008588460072538588460072530858846007253

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 Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 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
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
00858846007192MinXrayCMDR.TW.120.60.R2017-08-05

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