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Axir-Cx

FDA UDI

Class II (US FDA UDI)

by Radisen Co., Ltd.

Identity

Trade Name
AXIR-CX FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
Radiological Image Processing System FDA UDI
Model / Reference
AXIR-CX FDA UDI
Description
Radiological Image Processing System FDA UDI

Identifiers

Catalog Number
AXIR-CX FDA UDI
Primary DI / UDI-DI
08800099500076 FDA UDI
510(k) Number
K213520 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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: Diagnostic x-ray digital imaging system workstation

Axir-Cx by Radisen Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Radisen Co., Ltd.

Sources (1)

  • FDA UDI b5f3eee3-9bb7-4608-ac62-76a6fd492e05 35 fields · synced May 30, 2026