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RadiForce®

FDA UDI

Class II (US FDA UDI)

by Eizo Corporation

Identity

Trade Name
RadiForce® FDA UDI
Generic Name
Image display unit, monochrome FDA UDI
Device Name
5MP Monochrome LCD Monitor FDA UDI
Model / Reference
GX560 FDA UDI
Description
5MP Monochrome LCD Monitor FDA UDI

Identifiers

Catalog Number
GX560-BK-MD FDA UDI
Primary DI / UDI-DI
04995047059165 FDA UDI
510(k) Number
K181609 FDA UDI
FDA Product Code
PGY FDA UDI
GMDN Term
Image display unit, monochrome 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: Image display unit, monochrome

RadiForce is a high-performance, monochrome LCD monitor designed for diagnostic radiology applications. Featuring a 5MP resolution and a 2-inch display, this device provides clear and crisp visuals for medical professionals. With its compact size and lightweight design, RadiForce is ideal for use in small operating rooms or for mobile imaging. The device has been premarket-submitted to regulatory agencies for approval before entering the market.

Similar devices

Also classified as Image display unit, monochrome.

Cleared under the same submission

K181609 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Eizo Corporation

Sources (1)

  • FDA UDI db1325a6-6b89-4259-a7ef-b7fc19285784 36 fields · synced Jul 25, 2026