MinXray

GUDID 00858846007062

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.

MINXRAY, INC.

Mobile basic diagnostic x-ray system, digital
Primary Device ID00858846007062
NIH Device Record Key8dab9525-fa0c-4d5c-809f-f7d173a67670
Commercial Distribution StatusIn Commercial Distribution
Brand NameMinXray
Version Model NumberCMDR.PE.100.S
Company DUNS042071001
Company NameMINXRAY, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-221-2245
Emailservice@minxray.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100858846007062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-04

On-Brand Devices [MinXray]

00861050000347This product represents the straightforward interconnection of three devices: either the HF120/6
00861050000330This product represents the straightforward interconnection of three devices: either the HF120/6
00861050000323This is a portable line operated diagnostic x-ray unit. It is a high power (4kW), heavy duty me
00861050000316The MinXray model HF100H+ is a mono-block type high frequency portable x-ray unit. The HF100H+ c
00861050000309The MinXray model HF120/60HPPVW is a mono-block type high frequency portable x-ray unit. The uni
00858846007253The TR90BH is a portable X-ray system with following limitations of use: The device may be used
00858846007246This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007239This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007222This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007215This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007208This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007192This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007185This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007178This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007161This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007154This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007147This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007130This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007123This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007116This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007109This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007093This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007086This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007079This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007062This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007055This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007048This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007031This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007024This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007017This device is intended for use by a qualified/trained physician or technician on both adult and
00858846007000This device is intended for use by a qualified/trained physician or technician on both adult and

Trademark Results [MinXray]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MINXRAY
MINXRAY
73003630 1006245 Live/Registered
MINXRAY, INC.
1973-10-15

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