ImmersiveTouch

GUDID B940IMMERSIVEVIEW50

ImmersiveTouch is a stand-alone modular software package that allows users to import, visualize, and segment medical images to create accurate 3D representations.

IMMERSIVETOUCH, INC.

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• Primary Device ID: B940IMMERSIVEVIEW50
• NIH Device Record Key: ee980752-d556-4557-a0f1-9be0e7807454
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmersiveTouch
• Version Model Number: V5.0
• Company DUNS: 801390100
• Company Name: IMMERSIVETOUCH, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B940IMMERSIVEVIEW50 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210726

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-09-05
• Device Publish Date: 2023-08-28

On-Brand Devices [ImmersiveTouch]

• B940IVZBKIT0: ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch
• B940IMMERSIVEVIEW0: The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluati
• B940IMMERSIVEVIEW50: ImmersiveTouch is a stand-alone modular software package that allows users to import, visualize,