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Millennium 120-leaf Multileaf Collimator

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
Millennium 120-leaf Multileaf Collimator FDA UDI
Generic Name
Automatic-aperture-control accelerator system collimator FDA UDI
Model / Reference
8.1 FDA UDI

Identifiers

Primary DI / UDI-DI
00899475002127 FDA UDI
510(k) Number
K133240 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Automatic-aperture-control accelerator system collimator 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Automatic-aperture-control accelerator system collimator

Millennium 120-leaf Multileaf Collimator by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic-aperture-control accelerator system collimator.

Cleared under the same submission

K133240 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varian Medical Systems, Inc

Sources (1)

  • FDA UDI 6a044cf6-e0ea-490e-b6b0-5db3bef8cbca 33 fields · synced May 30, 2026