Angiowave Imaging, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3021027284
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What Angiowave Imaging, Inc. makes
Angiowave Imaging, Inc. develops AngioWaveNet, a medical imaging system designed for intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) integration, enabling real-time coronary artery assessment during interventional procedures.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. AngioWaveNet is listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
AngioWaveNet Ref K244002
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3021027284
- Address
- 82 Alden Rd, Concord, MA, 01742
Frequently asked questions
How many devices does ANGIOWAVE IMAGING, INC. have in the registry?
The registry currently lists 2 devices for ANGIOWAVE IMAGING, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ANGIOWAVE IMAGING, INC.'s devices?
Among its 2 most recently registered devices, ANGIOWAVE IMAGING, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ANGIOWAVE IMAGING, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for ANGIOWAVE IMAGING, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ANGIOWAVE IMAGING, INC. in the registry?
The most recently registered devices listed for ANGIOWAVE IMAGING, INC. include Angiowave AngioWaveNet and AngioWaveNet.