MinXray - This device is intended for use by a - MINXRAY, INC.

Duns Number:042071001

Device Description: This device is intended for use by a qualified/trained physician or technician on both adu 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.

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More Product Details

Catalog Number

-

Brand Name

MinXray

Version/Model Number

CMDR.PE.1202.S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171353

Product Code Details

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Device Record Status

Public Device Record Key

f56d142e-3f96-498c-88cc-ce457638fc62

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MINXRAY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26