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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
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. FDA UDI
Model / Reference
TR90BH FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00858846007253 FDA UDI
510(k) Number
K182207 FDA UDI
FDA Product Code
IZL FDA UDI
GMDN Term
Portable basic diagnostic x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Minxray, Inc.

Sources (1)

  • FDA UDI 94c034e1-f68d-4247-a49e-9662cade8942 36 fields · synced May 30, 2026