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MinXray

FDA UDI

Class II (US FDA UDI)

by Minxray, Inc.

Identity

Trade Name
MinXray FDA UDI
Generic Name
Portable basic diagnostic x-ray system, analogue FDA UDI
Device Name
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. FDA UDI
Model / Reference
CMDR.TW.1202.R FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00858846007222 FDA UDI
510(k) Number
K171353 FDA UDI
FDA Product Code
LLZ FDA UDI
MQB FDA UDI
IZL FDA UDI
GMDN Term
Portable basic diagnostic x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
892.1680 FDA UDI
892.1720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Portable basic diagnostic x-ray system, analogue

MinXray by Minxray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Portable basic diagnostic x-ray system, analogue.

Cleared under the same submission

K171353 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Minxray, Inc.

Sources (1)

  • FDA UDI 334c8581-7dc1-4722-bafb-4386877ab354 36 fields · synced May 30, 2026