Quantified Signal Imaging, Inc.
CanadaFDA applicant, unverified
- Devices
- 3
What Quantified Signal Imaging, Inc. makes
Quantified Signal Imaging, Inc. manufactures ultrasound imaging systems, including the QSI 9500 and QSI 9000 series, as well as the QUANTIMAP III software tool for quantitative cardiac imaging analysis. These devices are designed for cardiac and vascular assessments, providing real-time imaging and advanced measurement capabilities for diagnostic purposes.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. These devices are intended for use in the United States, where regulatory compliance is maintained through the FDA’s premarket notification pathway.
Catalogue
Qsi 9500 Ref K904294
Regimes: 510(k) Registry: 510(k)Quantimap Iii Ref K863650
Regimes: 510(k) Registry: 510(k)Qsi 9000 Ref K894560
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Quantified Signal Imaging, Inc. have in the registry?
The registry currently lists 3 devices for Quantified Signal Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quantified Signal Imaging, Inc.'s devices?
Among its 3 most recently registered devices, Quantified Signal Imaging, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Quantified Signal Imaging, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Quantified Signal Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quantified Signal Imaging, Inc. in the registry?
The most recently registered devices listed for Quantified Signal Imaging, Inc. include QSI 9500, QUANTIMAP III and QSI 9000.