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FCR 1Shot Phantom Plus

FDA UDI

Class I (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FCR 1Shot Phantom Plus FDA UDI
Generic Name
General-purpose diagnostic x-ray phantom, test object FDA UDI
Device Name
1 Shot Phantom Plus is used for quality control of digital Radiography systems. FDA UDI
Model / Reference
FCR 1SHOT PHANTOM PLUS MDR E FDA UDI
Description
1 Shot Phantom Plus is used for quality control of digital Radiography systems. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410538861 FDA UDI
FDA Product Code
LHO FDA UDI
GMDN Term
General-purpose diagnostic x-ray phantom, test object FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1940 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose diagnostic x-ray phantom, test object

FCR 1Shot Phantom Plus by FUJIFILM Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose diagnostic x-ray phantom, test object.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 7304967c-afea-4d8d-9dc9-829e2ba34583 35 fields · synced May 30, 2026