Data / Medical devices / X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (QHA): 4 FDA-registered makers in 2 countries
4 establishments in 2 countries are registered with the FDA to make X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device (product code QHA, Class 2, 21 CFR 892.1600). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on October 17, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QHA
- Device class
- 2
- Regulation
- 892.1600
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| Netherlands | 3 |
| United States | 1 |
Makers of X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medis Medical Imaging Systems, B.V. | LEIDEN Zuid-Holland, Netherlands | Manufacturer | 1 | May 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Pie Medical Imaging B.V. | MAASTRICHT Limburg, Netherlands | Manufacturer | 1 | April 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| QFR Solutions BV | Leiden Zuid-Holland, Netherlands | Manufacturer | 1 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Spectrawave, Inc. | Bedford, MA, United States | Manufacturer | 1 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated October 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.