Device
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...
Manufacturer
AngioWave Imaging, LLC
AngioWave Imaging, LLC
Model: AngioWaveNet
DI: 00198715128956
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-20
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
0ce38150-fd1e-4a3e-b9c3-9a4760530deb
Distribution Status:
In Commercial Distribution
DUNS Number:
118267492
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198715128956
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
QIH
Automated Radiological Image Processing Software
OWB
Interventional Fluoroscopic X-Ray System
Premarket Submissions
Submission Number:
K244002
Supplement Number:
000