HeartFlow Analysis
Basic Information
- Brand Name
- HeartFlow Analysis
- Primary DI
- 00853341006060
- Version / Model
- FFRct version 3
- Company Name
- Heartflow, Inc.
- Labeler DUNS
- 804411283
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-21
- Public Version
- 1
- Public Version Date
- 2022-12-29
- Public Version Status
- New
- Public Device Record Key
- b267b434-e20a-48cb-9bed-b72ef165d7fe
Device Description
The HeartFlow Analysis is AI-based medical device software developed for the clinical quantitative and qualitative analysis of CT DICOM data. It is a tool for the analysis of CT DICOM-compliant cardiac images and data, to assess the anatomy and function of the coronary arteries in the risk stratification and evaluation of coronary artery disease. The software displays coronary anatomy and functional information using graphics and text, including computed and derived quantities of percent stenosis, plaque volumes, blood flow, pressure and velocity, to aid the clinician in the assessment and treatment planning of coronary artery disease. The HeartFlow Analysis is performed on previously physician-acquired image data and are unrelated to acquisition equipment and clinical workstations.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| PJA | Coronary Vascular Physiologic Simulation Software | Cardiovascular | 870.1415 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61213 | Vascular modelling software | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853341006060 | GS1 |
Customer Contacts
- Phone
- 6502410500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213857 | 000 |