Smart Segmentation - Knowledge Based Contouring

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Imaging Laboratory GmbH

Identity

Trade Name: Smart Segmentation - Knowledge Based Contouring FDA UDI
Generic Name: Radiation therapy software FDA UDI
Model / Reference: 15.0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00856100006011 FDA UDI
510(k) Number: K141248 FDA UDI
FDA Product Code: MUJ FDA UDI
GMDN Term: Radiation therapy software 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: Radiation therapy software

Smart Segmentation - Knowledge Based Contouring by Varian Medical Systems Imaging Laboratory GmbH — 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 Imaging Laboratory GmbH

Sources (1)

FDA UDI f2a9d36b-be6c-4022-a420-f45ef5c56dec 33 fields · synced May 29, 2026