TomoHDA® Treatment Delivery System

FDA UDI

Class II (US FDA UDI)

by Accuray Incorporated

Identity

Trade Name: TomoHDA® Treatment Delivery System FDA UDI
Generic Name: Linear accelerator system FDA UDI
Device Name: TomoTherapy Treatment System (H Series) FDA UDI
Model / Reference: 1018286-000 FDA UDI
Description: TomoTherapy Treatment System (H Series) FDA UDI

Identifiers

Catalog Number: NA FDA UDI
Primary DI / UDI-DI: M65810182860 FDA UDI
FDA Product Code: IYE FDA UDI
MUJ 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Linear accelerator system

TomoHDA® Treatment Delivery System by Accuray Incorporated — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Accuray Incorporated

Sources (1)

FDA UDI 5af6ee70-357e-400a-b028-439265e63188 35 fields · synced Jun 9, 2026