Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1600](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1600) → QHA — X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

# QHA · X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

_Radiology · 21 CFR 892.1600 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA

## Overview

- **Product Code:** QHA
- **Device Name:** X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- **Regulation:** [21 CFR 892.1600](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1600)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Classification Rationale

Class II.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251355](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K251355.md) | X1-FFR | Spectrawave, Inc. | Oct 17, 2025 | SESE |
| [K243769](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K243769.md) | QFR (3.0) | Qfr Solutions BV | Apr 4, 2025 | SESE |
| [K232147](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K232147.md) | CAAS Workstation | Pie Medical Imaging BV | Apr 9, 2024 | SESE |
| [K230303](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K230303.md) | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | Mar 2, 2023 | SESE |
| [K221711](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K221711.md) | AccuICAS | ArteryFlow Technology Co., Ltd. | Feb 28, 2023 | SESE |
| [K210093](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K210093.md) | AccuFFRangio | ArteryFlow Technology Co., Ltd. | Sep 10, 2021 | SESE |
| [K182611](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA/K182611.md) | Qangio XA 3D | Medis Medical Imaging Systems BV | May 30, 2019 | SESE |

## Top Applicants

- ArteryFlow Technology Co., Ltd. — 3 clearances
- Medis Medical Imaging Systems BV — 1 clearance
- Pie Medical Imaging BV — 1 clearance
- Qfr Solutions BV — 1 clearance
- Spectrawave, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/QHA)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com