Caption AI (Caption Guidance + Caption Interpretation)

GUDID 00860003586341

CAPTION HEALTH, INC.

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• Primary Device ID: 00860003586341
• NIH Device Record Key: fc2b2f3c-085f-4c2c-9051-9ab2870a69a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caption AI (Caption Guidance + Caption Interpretation)
• Version Model Number: Alastor
• Company DUNS: 079192179
• Company Name: CAPTION HEALTH, INC.
• 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: true
• Serial Number: false
• 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	00860003586341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN190040

FDA Product Code

• QJU: Image Acquisition And/Or Optimization Guided By Artificial Intelligence

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: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [Caption AI (Caption Guidance + Caption Interpretation)]

• 00860003586303: The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiogr
• 00860003586310: Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound. The Capt
• 00860003586341: Alastor