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AlignRT Plus

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref Fujitsu M7010X workstation

by Vision RT Ltd.

Identity

Trade Name
AlignRT Plus FDA UDI
Generic Name
Radiological video camera patient positioning/tracking system FDA UDI
Device Name
AlignRT Plus EUDAMED
Model / Reference
Fujitsu M7010X workstation EUDAMED
Fujitsu M7010X FDA UDI

Identifiers

Primary DI / UDI-DI
05056190500665 EUDAMEDFDA UDI
Basic UDI-DI
5056190500573VE EUDAMED
Direct Marketing DI
05056190500665 EUDAMED
510(k) Number
K203387 FDA UDI
FDA Product Code
IYE FDA UDI
EMDN Code
Z11019099 VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHER EUDAMED
GMDN Term
Radiological video camera patient positioning/tracking system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

The AlignRT Plus is a Computer-Assisted Radiation Therapy (CART) System (Nomenclature Code: Z11019099), designed for real-time image-guided radiation therapy. It integrates with the Fujitsu M7010X workstation to provide precise patient positioning and alignment, enhancing treatment accuracy during external beam radiotherapy sessions. Classified as a Class IIb medical device, it supports adaptive workflows to reduce setup errors and improve dose delivery consistency.

AlignRT Plus is supplied as a non-sterile, non-reusable system intended for use in radiation oncology departments. It operates in conjunction with MRI-safe environments and is compatible with standard radiation therapy infrastructure. The device requires proper calibration and maintenance as specified by the manufacturer, adhering to FDA 510K and MDR regulatory standards. Storage and handling follow manufacturer guidelines to ensure operational integrity and compliance with medical device regulations.

Frequently asked questions

What is the AlignRT Plus designed to improve in radiation therapy treatments and how does it achieve this?

The AlignRT Plus is designed to enhance treatment accuracy in external beam radiotherapy by providing real-time image-guided alignment. It integrates with the Fujitsu M7010X workstation to ensure precise patient positioning, reducing setup errors and improving dose delivery consistency through adaptive workflows.

Is the AlignRT Plus system reusable or single-use, and what are the implications for sterility?

The AlignRT Plus is a non-reusable system, meaning it is intended for single-use in radiation oncology departments. Since it is non-sterile, it does not require sterilization between uses, but proper handling and maintenance are still critical to ensure operational integrity and compliance with regulatory standards.

What regulatory pathways has the AlignRT Plus followed, and what does this mean for its use in clinical settings?

The AlignRT Plus has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with stringent safety and performance standards. This means it can be legally marketed and used in clinical settings in the U.S. and EU, adhering to the respective regulatory requirements for Class IIb devices.

How does the AlignRT Plus integrate with existing radiation therapy infrastructure, and are there any specific environmental requirements?

The AlignRT Plus is compatible with standard radiation therapy infrastructure and is designed to operate in MRI-safe environments. While it integrates with the Fujitsu M7010X workstation for precise alignment, no additional environmental modifications are required beyond those already present in radiation oncology departments.

What maintenance or calibration steps are necessary to ensure the AlignRT Plus functions correctly over time?

The AlignRT Plus requires proper calibration and maintenance as specified by Vision RT Ltd. to ensure accurate performance. Adhering to the manufacturer’s guidelines is essential for compliance with FDA 510(k) and MDR standards, as well as for maintaining the device’s operational integrity and treatment precision.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Vision RT Ltd.
EUDAMED SRN
GB-MF-000010499
Authorised Representative
Oticon A/S DK-AR-000006135

Sources (3)

  • EUDAMED dedf96f2-010e-4830-a65b-7edf4d97ff1a 61 fields · synced Sep 18, 2026
  • FDA UDI 58a0d6c2-efab-4040-9afb-c4fa1c3a6d2b 34 fields · synced May 27, 2026
  • FDA 510(k) K203387 1 fields · synced May 18, 2026