DEEPVESSEL

Primary DI
06974636510087
Brand
DEEPVESSEL
Company
Keya Medical Technology Co., Ltd.
Model
V1.1
Device description
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.
Published
2025-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PJACoronary Vascular Physiologic Simulation Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJACoronary Vascular Physiologic Simulation SoftwareCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213657000DEEPVESSEL FFRKeyamed Na, Inc.2022-04-01PJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974636510087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974636510087069746365100876974636510087

GMDN Terms#

Term, Definition table
TermDefinition
Vascular modelling softwareA stand-alone software application intended to aid assessment of vascular stenosis and/or endovascular interventions, by producing a three-dimensional (3-D) cardiovascular model which has features of predicted blood flow data and/or endovascular device deployments. It typically uses computed tomography (CT) images and may be intended as an alternative to invasive techniques (i.e., invasive blood pressure, invasive fractional flow reserve, angiography); it is not intended to store patient records. It is designed to be installed on an off-the-shelf computer/smart device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
551093357
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853341006701Heartflow AnalysisHeartflow, Inc.PJA2025-09-20
00853341006060HeartFlow AnalysisHeartflow, Inc.PJA2022-12-21
00853341006053HeartFlow AnalysisHeartflow, Inc.PJA2021-06-08
00853341006039HeartFlow AnalysisHeartflow, Inc.PJA2020-04-08
00853341006022FFRctHeartflow, Inc.PJA2019-02-01
00853341006015FFRctHeartflow, Inc.PJA2016-12-06
00853341006008FFRctHeartflow, Inc.PJA2016-08-01