MapRT

GUDID 05056190500924

MapRT system

VISION RT LIMITED

Radiological video camera patient positioning/tracking system

• Primary Device ID: 05056190500924
• NIH Device Record Key: bec09ee6-ce90-464a-8153-8f596b8073be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MapRT
• Version Model Number: MapRT system
• 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	05056190500924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243301

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: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [MapRT]

• 05056190501273: HP Z2 G9 workstation - MapRT
• 05056190501099: MapRT couch markers
• 05056190501051: MapRT Capture (v1.2)
• 05056190501044: MapRT Mapping application (v1.2)
• 05056190500924: MapRT system