Qfr Solutions BV
NetherlandsFDA 510(k) applicant, unverified FDA FEI 3038136528
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Qfr Solutions BV makes
Qfr Solutions BV manufactures QFR (3.0), a software tool designed for quantitative flow ratio (QFR) analysis in coronary angiography. This digital solution enables physicians to assess coronary artery stenosis by simulating invasive pressure measurements using pre-existing angiographic images, supporting decision-making for percutaneous coronary interventions.
The QFR (3.0) software is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Qfr (3.0) Ref K243769
510(k) 510(k)
Company details
- FDA FEI number
- 3038136528
- Address
- Schuttersveld 9, Leiden Zuid-Holland
Frequently asked questions
How many devices does Qfr Solutions BV have in the registry?
The registry currently lists 1 device for Qfr Solutions BV. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qfr Solutions BV's devices?
Among its 1 most recently registered device, Qfr Solutions BV has devices listed in FDA 510(k) (1 device).
What risk classes do Qfr Solutions BV's devices fall under?
Among its 1 most recently registered device, the classes recorded for Qfr Solutions BV's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qfr Solutions BV in the registry?
The most recently registered devices listed for Qfr Solutions BV include QFR (3.0).