Angiowave

Primary DI
00198715128956
Brand
Angiowave
Company
AngioWave Imaging, LLC
Model
AngioWaveNet
Device description
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.
Published
2026-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244002000AngioWaveNetAngiowave Imaging, Inc.2025-09-10QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198715128956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198715128956001987151289561987151289560198715128956

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopic x-ray system operation software"A mainframe or personal computer (PC) based operating system software (or firmware) specific to the central processing unit (CPU) incorporated into a general-purpose fluoroscopic x-ray system configuration. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a ""version number"" are commonly used identify different operating system versions."

Contacts#

Phone, Email table
PhoneEmail
1-617-901-8989info@angiowave.ai

Regulatory Flags#

DUNS number
118267492
Device count
1
Lot or batch
true
Manufacturing date on label
true

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