FDA.reportPublic FDA data

ANGIOWAVE IMAGING, INC.

Matched from indexed company URL: AngioWave Imaging, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30210272843021027284ANGIOWAVE IMAGING, INC.1N2026-01-0182 Alden Rd Concord MA US 01742

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00198715128956Angiowave - AngioWaveNet is indicated for use by qualified physicians or under their supervision to aid in the analysis and interpretation of X-ray coronary angiographic cines. AngioWaveNet is intended for use in adults during X-ray coronary angiographic imaging procedures as a clinically useful complement to the viewing of standard angiographic cines acquired during diagnostic coronary angiography procedures. AngioWaveNet software is intended for use to enhance the visibility of blood vessels, vascular structures, and related anatomical features within angiographic images, which may be clinically useful to the treating physician.1-617-901-8989info@angiowave.ai

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3443981947908749K244002AngioWaveNetQIH2025-09-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QIH12025-09-10

GUDID#

Angiowave - AngioWaveNet is indicated for use by qualified physicians or under their supervision to aid in the analysis and interpretation of X-ray coronary angiographic cines. AngioWaveNet is intended for use in adults during X-ray coronary angiographic imaging procedures as a clinically useful complement to the viewing of standard angiographic cines acquired during diagnostic coronary angiography procedures. AngioWaveNet software is intended for use to enhance the visibility of blood vessels, vascular structures, and related anatomical features within angiographic images, which may be clinically useful to the treating physician.

AngioWave Imaging, LLC

2026-05-09