510(k) K182611
- Device
- Qangio XA 3D
- Applicant
- Medis Medical Imaging Systems Bv
- 510(k) number
- K182611
- Product code
- QHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-30
- Date received
- 2018-09-21
- Regulation
- 892.1600
- Classification name
- X-ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- B. Goedhart
- Address
- Schuttersveld 9 Leiden NL 2316XG 2316XG
FDA Registration Numbers#
- 9614587
- 3038136528
- 3017654247
- 9710122
Source Documents#
Other 510(k) Records For Product Code QHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251355 | X1-FFR | Spectrawave, Inc. | 2025-10-17 |
| K243769 | QFR (3.0) | Qfr Solutions BV | 2025-04-04 |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024-04-09 |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023-02-28 |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
Legacy Summary#
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FDA Review#
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