Deepvessel

DEEPVESSEL FFR is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically…

Registry build 21.09.26

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.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code PJA
Manufacturer City Province Registered as Device types
Keya Medical Technology Co., Ltd. Beijing Beijing Manufacturer 2

Record

Regulatory record for Deepvessel
Listed by Keya Medical Technology Co., Ltd., China
FDA product code PJA
Device type Coronary Vascular Physiologic Simulation Software
Device class Class 2
Regulation 21 CFR 870.1415
Establishment Manufacturer
510(k) K213657
Record published 2025-12-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information

Catalogue Numbers

Catalogue numbers for Deepvessel
Catalogue number Size Status
V1.1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
FFRct Heartflow, Inc. 3
HeartFlow Analysis Heartflow, Inc. 2

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer