Ikshana

GUDID B940IKSHANA0

Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors. Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists. When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.

IMMERSIVETOUCH, INC.

Radiology DICOM image processing application software

• Primary Device ID: B940IKSHANA0
• NIH Device Record Key: 9fd776db-115d-467e-9683-45bdcb1dbb20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ikshana
• Version Model Number: V1.0
• 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	B940IKSHANA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230249

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: 2024-05-08
• Device Publish Date: 2024-04-30

Devices Manufactured by IMMERSIVETOUCH, INC.

• B940IKSHANA0 - Ikshana: 2024-05-08Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements, and 3D visualization. Medical images may only be interpreted using an FDA-cleared display monitor that meets technical specifications that are reviewed and accepted by the FDA. Ikshana is intended to be used as an adjunct to the interpretation of images performed using diagnostic imaging systems and is not intended for primary diagnosis. Display monitors used for reading medical images for diagnostic purposes must be FDA-approved radiology monitors. Ikshana software is indicated for use by qualified healthcare professionals, including, but not restricted to, radiologists, non-radiology specialists, physicians, and technologists. When accessing the Ikshana software from a wireless stereoscopic head-mounted display (HMD) or mobile device, the images viewed are for informational purposes only and are not intended for diagnostic use.
• B940IKSHANA0 - Ikshana: 2024-05-08 Ikshana is a software device to display medical images. It includes functions for image review, image manipulation, measurements
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• B940IMMERSIVEVIEW0 - ImmersiveTouch: 2020-08-17 The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
• B940IVZBKIT0 - ImmersiveTouch: 2020-08-17 ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-ope