Model: R3.2 for iOS
DI: 00198953157152
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Vscan Air R3.2 for iOS
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
328ca3c4-90a0-4cc5-a5b1-a52df6203b18
Distribution Status:
In Commercial Distribution
DUNS Number:
518870571
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00198953157152
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
IYN
System, Imaging, Pulsed Doppler, Ultrasonic
IYO
System, Imaging, Pulsed Echo, Ultrasonic
ITX
Transducer, Ultrasonic, Diagnostic
Premarket Submissions
Submission Number:
K250087
Supplement Number:
000