FDA.reportPublic FDA data

MINXRAY, INC.

Matched from indexed company URL: MinXray, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14189601418960MINXRAY, INC.1Y2026-01-013611 COMMERCIAL AVE. NORTHBROOK IL US 60062

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00858846007000MinXray - 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 is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors800-221-2245service@minxray.com
00858846007017MinXray - 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 is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors800-221-2245service@minxray.com
00858846007024MinXray - 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 is a mono-block type high frequency portable x-ray unit. The unit can be used with conventional diagnostic film or with solid-state digital radiographic sensors800-221-2245service@minxray.com
00858846007031MinXray - 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.800-221-2245service@minxray.com
00858846007048MinXray - 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.800-221-2245service@minxray.com
00858846007055MinXray - 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.800-221-2245service@minxray.com
00858846007062MinXray - 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.800-221-2245service@minxray.com
00858846007253MinXray - 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.800-221-2245service@minxray.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
138001597108665K210479IMPACT and X-RangerIZL2021-03-19
138001471794938K201575CMDR 2C (Multiple Models)IZL2020-07-08
138001695612752K191451CMDR 2CW (Multiple models)IZL2019-07-03
138001119955149K171353CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisIZL2017-06-07
138001130807319K141885CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAYIZL2014-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IZL52021-03-19

PMN#

GUDID#

MinXray - 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.

MINXRAY, INC.

2019-01-14