Caption

GUDID 00198953038604

Caption Cardiac Guidance on Venue

Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc

Ultrasound imaging system application software

• Primary Device ID: 00198953038604
• NIH Device Record Key: d3030be7-6d89-4a35-a36d-72b2a05e0da8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caption
• Version Model Number: Guidance
• Company DUNS: 119309548
• Company Name: Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
• 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: false
• 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	00198953038604 [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: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [Caption]

• 00198953030233: Caption AI on Vscan
• 00198953038604: Caption Cardiac Guidance on Venue