MinXray

FDA UDI

Class II (US FDA UDI)

by Minxray, Inc.

Identity

Trade Name: MinXray FDA UDI
Generic Name: Mobile basic diagnostic x-ray system, digital 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.100.S 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: 00858846007093 FDA UDI
510(k) Number: K171353 FDA UDI
FDA Product Code: LLZ FDA UDI
MQB FDA UDI
IZL FDA UDI
GMDN Term: Mobile basic diagnostic x-ray system, digital 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mobile basic diagnostic x-ray system, digital

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

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Cleared under the same submission

K171353 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Minxray, Inc.

Sources (1)

FDA UDI d4772a64-5107-4435-b8de-58a02c12fa7f 36 fields · synced Jun 8, 2026