Coronary Vascular Physiologic Simulation Software
The Coronary Vascular Physiologic Simulation Software is a software device intended to aid in the identification of functionally significant cardiovascular disease by simulating coronary vascular physiology based on patient imaging data, helping clinicians evaluate whether coronary lesions are hemodynamically significant. It is an FDA Class 2 device regulated under 21 CFR 870.1415, requiring 510(k) premarket notification, within the Cardiovascular (CV) medical specialty. The product code is PJA. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PJA
- Device Class
- FDA class 2
- Regulation Number
- 870.1415
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250902 | HeartFlow Analysis | Jul 18, 2025 | Substantially Equivalent | HeartFlow, Inc. |
| K213857 | HeartFlow Analysis | Oct 14, 2022 | Substantially Equivalent | HeartFlow, Inc. |
| K213657 | DEEPVESSEL FFR | Apr 01, 2022 | Substantially Equivalent | Keyamed Na, Inc. |
| K203329 | HeartFlow Analysis | Jan 08, 2021 | Substantially Equivalent | HeartFlow, Inc. |
| K190925 | HeartFlow FFRct Analysis | Aug 15, 2019 | Substantially Equivalent | HeartFlow, Inc. |
| K182035 | FFRct | Dec 06, 2018 | Substantially Equivalent | HeartFlow, Inc. |
| K161772 | FFRct | Aug 24, 2016 | Substantially Equivalent | HeartFlow, Inc. |
| K152733 | FFRct | Jan 13, 2016 | Substantially Equivalent | HeartFlow, Inc. |
| DEN130045 | HEARTFLOW FFRCT | Nov 26, 2014 | Unknown | Heartflow |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.