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Multipurpose Remote Control R/F System

FDA UDI

Class II (US FDA UDI)

by Canon Medical Systems Corporation

Identity

Trade Name
MULTIPURPOSE REMOTE CONTROL R/F SYSTEM FDA UDI
Generic Name
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Device Name
MULTIPURPOSE REMOTE CONTROL R/F SYSTEM FDA UDI
Model / Reference
DREX-UI80 FDA UDI
Description
MULTIPURPOSE REMOTE CONTROL R/F SYSTEM FDA UDI

Identifiers

Primary DI / UDI-DI
04987670100147 FDA UDI
510(k) Number
K143281 FDA UDI
FDA Product Code
OWB FDA UDI
JAA FDA UDI
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 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

No

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

No

FDA UDI

Category: Stationary general-purpose fluoroscopic x-ray system, digital

Multipurpose Remote Control R/F System by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Canon Medical Systems Corporation

Sources (1)

  • FDA UDI d2bb40a8-98ea-4db2-afd1-e3c94cbefb14 35 fields · synced Jun 7, 2026