ScanNav Anatomy Peripheral Nerve Block

GUDID 05060878810021

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.

INTELLIGENT ULTRASOUND LIMITED

Ultrasound imaging system application software

• Primary Device ID: 05060878810021
• NIH Device Record Key: 401131ee-f384-4c32-b4d2-14c4ad9a8d84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanNav Anatomy Peripheral Nerve Block
• Version Model Number: V1.1
• Company DUNS: 218445981
• Company Name: INTELLIGENT ULTRASOUND LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05060878810021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220024

FDA Product Code

• QRG: Ultrasound Guided Nerve Block Assist

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: 2023-03-09
• Device Publish Date: 2023-03-01

On-Brand Devices [ScanNav Anatomy Peripheral Nerve Block]

• 05060878810021: ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) wh
• 05060878810052: ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) wh