Device
The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures from
Manufacturer
ULTRASIGHT LTD
ULTRASIGHT LTD
Model: V1
DI: 07290019208402
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
The PVAD IQ software is intended for non-invasive analysis of ultrasound images to detect and measure structures from
cardiac ultrasound of patients 18 years old and above, with a Percutaneous Ventricular Assist Device (PVAD). Such use is
typically utilized for clinical decision support by a qualified physician.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f7164d20-75da-4da7-8c37-36cf490e24cd
Distribution Status:
In Commercial Distribution
DUNS Number:
521106393
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07290019208402
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40873
Name: Ultrasound imaging system application software
Definition:
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
FDA Product Codes
QIH
Automated Radiological Image Processing Software
Premarket Submissions
Submission Number:
K252235
Supplement Number:
000