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Micro-X

FDA UDI

Class II (US FDA UDI)

by Micro-X , Ltd.

Identity

Trade Name
Micro-X FDA UDI
Generic Name
Mobile basic diagnostic x-ray system, digital FDA UDI
Device Name
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas FDA UDI
Model / Reference
Rover FDA UDI
Description
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas FDA UDI

Identifiers

Catalog Number
MXU-RV35 FDA UDI
Primary DI / UDI-DI
09357123000037 FDA UDI
510(k) Number
K211423 FDA UDI
FDA Product Code
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
892.1680 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: Mobile basic diagnostic x-ray system, digital

Micro-X by Micro-X , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mobile basic diagnostic x-ray system, digital.

Cleared under the same submission

K211423 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro-X , Ltd.

Sources (1)

  • FDA UDI 2134951a-defa-4b80-9c82-cad0b4d21012 36 fields · synced May 30, 2026