Geometric QA Phantom

FDA UDI

Class I (US FDA UDI)

by Philips Oy

Identity

Trade Name: Geometric QA Phantom FDA UDI
Generic Name: MRI phantom, test object FDA UDI
Device Name: The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application. FDA UDI
Model / Reference: 459800438932 FDA UDI
Description: The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application. FDA UDI

Identifiers

Primary DI / UDI-DI: 00884838068506 FDA UDI
FDA Product Code: LHO FDA UDI
GMDN Term: MRI 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: MRI phantom, test object

Geometric QA Phantom by Philips Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Philips Oy

Sources (1)

FDA UDI 2a6fc827-a460-47f2-ad39-a6a8f3998484 34 fields · synced Jun 8, 2026