Coronary Vascular Physiologic Simulation Software

PJA · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1415

Classification

FDA Product Code: PJA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1415
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown