Unique Single Energy Medical Charged Particle Radiation Therapy System

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name: Unique Single Energy Medical Charged Particle Radiation Therapy System FDA UDI
Generic Name: Linear accelerator system FDA UDI
Model / Reference: 9.1 FDA UDI

Identifiers

Catalog Number: CLL001009000 FDA UDI
Primary DI / UDI-DI: 00857235006013 FDA UDI
510(k) Number: K132705 FDA UDI
FDA Product Code: IYE FDA UDI
GMDN Term: Linear accelerator system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5050 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Linear accelerator system

Unique Single Energy Medical Charged Particle Radiation Therapy System by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID

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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 II	Pending data

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Manufacturer

Manufacturer: Varian Medical Systems, Inc

Sources (1)

FDA UDI e7df05e2-dfbe-4ed3-971a-d8b678b3d6c0 34 fields · synced May 31, 2026