Device
The Astrasono A3Essential Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the l...
Manufacturer
Astrasono technology co.,ltd.
Astrasono technology co.,ltd.
Model: A3Essential
DI: 16978669290036
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
The Astrasono A3Essential Scanner is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
de7c8346-8b4f-409f-9fa4-0414754a5a93
Distribution Status:
In Commercial Distribution
DUNS Number:
449989331
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
16978669290036
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41501
Name: Bladder volume ultrasound imaging system
Definition:
An assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound transducer which together reproduce digitized data of the bladder, typically bladder volume and post-void residual (PVR), and images. It will generate ultrasound pulses, direct them to a the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic three-dimensional (3-D) data/images. It is used in the diagnosis of urinary retention and postoperative urinary retention (POUR).
FDA Product Codes
IYO
System, Imaging, Pulsed Echo, Ultrasonic
ITX
Transducer, Ultrasonic, Diagnostic
Premarket Submissions
Submission Number:
K250331
Supplement Number:
000