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Integrated Collimator Verification and Interlock System (ICVI)

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems, Inc

Identity

Trade Name
Integrated Collimator Verification and Interlock System (ICVI) FDA UDI
Generic Name
Fixed-aperture therapeutic x-ray system collimator FDA UDI
Model / Reference
1 FDA UDI

Identifiers

Primary DI / UDI-DI
00899475002035 FDA UDI
510(k) Number
K123788 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Fixed-aperture therapeutic x-ray 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: Fixed-aperture therapeutic x-ray system collimator

Integrated Collimator Verification and Interlock System (ICVI) by Varian Medical Systems, Inc — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Fixed-aperture therapeutic x-ray system collimator.

Cleared under the same submission

K123788 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 ad5e728e-04db-4ff4-bca2-6272b7cfc567 33 fields · synced May 30, 2026