DEEPVESSEL

GUDID 06974636510087

DEEPVESSEL FFR is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides DVFFR (a CT-derived FFR measurement) computed from static coronary CTA images using deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries through learning. DEEPVESSEL FFR analysis is intended to support the functional evaluation of coronary artery disease. The results of the analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. DEEPVESSEL FFR results are intended to be used by qualified clinicians in conjunction with the with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

Keya Medical Technology Co., Ltd.

Vascular modelling software

• Primary Device ID: 06974636510087
• NIH Device Record Key: cc5b7b25-e88f-41c7-b079-0b3b314a1d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEEPVESSEL
• Version Model Number: V1.1
• Company DUNS: 551093357
• Company Name: Keya Medical Technology Co., Ltd.
• 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: false
• 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
GS1	06974636510087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213657

FDA Product Code

• PJA: Coronary Vascular Physiologic Simulation Software

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: 2025-12-30
• Device Publish Date: 2025-12-22