DoseRT reference board DoseRT reference board

GUDID 05056190500894

DoseRT reference board used with AlignRT Plus systems.

VISION RT LIMITED

Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system

• Primary Device ID: 05056190500894
• NIH Device Record Key: bfc4b300-baa3-4f1b-92ae-af67197486be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DoseRT reference board
• Version Model Number: DoseRT reference board
• Catalog Number: DoseRT reference board
• Company DUNS: 222160801
• Company Name: VISION RT LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056190500894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233622

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-11
• Device Publish Date: 2024-04-03

Devices Manufactured by VISION RT LIMITED

• 05056190500726 - AlignRT 7.3 (software): 2024-04-11 AlignRT 7.3 (software) used on AlignRT Plus systems
• 05056190500740 - DoseRT camera: 2024-04-11 DoseRT camera used for AlignRT Plus systems.
• 05056190500825 - Patient ID Module: 2024-04-11 Patient ID Module used as accessory to AlignRT Plus
• 05056190500894 - DoseRT reference board: 2024-04-11DoseRT reference board used with AlignRT Plus systems.
• 05056190500894 - DoseRT reference board: 2024-04-11 DoseRT reference board used with AlignRT Plus systems.
• 05056190500887 - MapRT Web app: 2023-12-21 MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be mod
• 05056190500757 - MapRT acquisition software: 2023-07-04 MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be mod
• 05056190500771 - MapRT Web app: 2023-07-04 MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be mod
• 05056190500214 - AlignRT Plus: 2023-06-16 Workstation Z4 - IGC TrueBeam AlignRT