510(k) K243769
- Device
- QFR (3.0)
- Applicant
- Qfr Solutions BV
- 510(k) number
- K243769
- Product code
- QHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-04
- Date received
- 2024-12-06
- 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
- N
Related Records
Applicant Contact
- Contact
- Bob 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
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|---|---|---|---|
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| 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 |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019-05-30 |