Ic Profiler-Mr

FDA UDI

Class I (US FDA UDI)

by Sun Nuclear Corp.

Identity

Trade Name: IC PROFILER-MR FDA UDI
Generic Name: Accelerator system quality assurance device FDA UDI
Device Name: Radiation therapy QA device. FDA UDI
Model / Reference: 1123300Z FDA UDI
Description: Radiation therapy QA device. FDA UDI

Identifiers

Catalog Number: 1122000-0MRZ FDA UDI
Primary DI / UDI-DI: 05060608880768 FDA UDI
FDA Product Code: LHO FDA UDI
GMDN Term: Accelerator system quality assurance device 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Accelerator system quality assurance device

Ic Profiler-Mr by Sun Nuclear Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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StereoPHAN — Sun Nuclear Corporation · Class I
Detector Holder — IBA Dosimetry GmbH · Class II
myQA®Daily (Software) — IBA Dosimetry GmbH · Class I

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: Sun Nuclear Corp.

Sources (1)

FDA UDI 417193dc-95bb-490a-b219-366d68761e9c 35 fields · synced Jun 8, 2026