TomoTherapy Treatment Delivery System with iDMS

FDA UDI

Class II (US FDA UDI)

by Accuray Incorporated

Identity

Trade Name: TomoTherapy Treatment Delivery System with iDMS FDA UDI
Generic Name: Linear accelerator system FDA UDI
Device Name: The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. FDA UDI
Model / Reference: 1068286 FDA UDI
Description: The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. FDA UDI

Identifiers

Catalog Number: NA FDA UDI
Primary DI / UDI-DI: M65810682860 FDA UDI
510(k) Number: K171837 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

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

TomoTherapy Treatment Delivery System with iDMS by Accuray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Linear accelerator system.

Clinac iX — Varian Medical Systems, Inc · Class II
LIAC — Sit Sordina Iort Technologies Spa · Class II
Head Coil (Receive Only) — VIEWRAY INCORPORATED · Class II
Elekta Unity — Elekta Inc. · Class II
Varian Collimator Accessories 30 CM wedge set upper (JITKIT) — Varian Medical Systems, Inc · Class II
Elekta Unity — Elekta Inc. · Class II
Elekta Unity — Elekta Inc. · Class II
VitalBeam — Varian Medical Systems, Inc · Class II

Cleared under the same submission

K171837 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Accuray Incorporated

Sources (1)

FDA UDI 7ffec45f-3732-4a37-8e25-5e4303e57275 36 fields · synced Jun 9, 2026