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AlignRT Plus

FDA UDI

Class II (US FDA UDI)

by Vision RT Limited

Identity

Trade Name
AlignRT Plus FDA UDI
Generic Name
Radiological video camera patient positioning/tracking system FDA UDI
Model / Reference
OSMS 5.1 115V FDA UDI

Identifiers

Primary DI / UDI-DI
05056190500122 FDA UDI
510(k) Number
K123371 FDA UDI
FDA Product Code
IYE FDA UDI
GMDN Term
Radiological video camera patient positioning/tracking 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

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: Radiological video camera patient positioning/tracking system

AlignRT Plus by Vision RT Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological video camera patient positioning/tracking system.

Cleared under the same submission

K123371 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vision RT Limited

Sources (1)

  • FDA UDI 41cc7129-d105-45af-b2e8-3832143ef079 34 fields · synced Jun 6, 2026