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Leksell Vantage Stereotactic System

FDA UDI

Class II (US FDA UDI)

by Elekta Solutions AB

Identity

Trade Name
Leksell Vantage Stereotactic System FDA UDI
Generic Name
Neurological stereotactic surgery system FDA UDI
Device Name
Leksell Vantage™ Head Frame FDA UDI
Model / Reference
1040036 FDA UDI
Description
Leksell Vantage™ Head Frame FDA UDI

Identifiers

Catalog Number
1040036 FDA UDI
Primary DI / UDI-DI
07340201502198 FDA UDI
510(k) Number
K190887 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Neurological stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
Not 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

Yes

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
MRI Safety
MR Safe FDA UDI

Leksell Vantage Stereotactic System by Elekta Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elekta Solutions AB

Sources (1)

  • FDA UDI e661f862-8856-45a1-b36c-3c2ce0e24797 37 fields · synced May 30, 2026