Astrasono A3Essential Bladder Scanner

Primary DI
16978669290036
Brand
Astrasono A3Essential Bladder Scanner
Company
Astrasono technology co.,ltd.
Model
A3Essential
Device 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.
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250331000Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd.2025-09-30IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16978669290036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697866929003616978669290036

GMDN Terms#

Term, Definition table
TermDefinition
Bladder volume ultrasound imaging systemAn 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).

Regulatory Flags#

DUNS number
449989331
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16978669290029Astrasono A3Pro Lite Bladder ScannerA3Pro Lite2026-05-12
16978669290012Astrasono A5Pro Bladder ScannerA5Pro 2026-01-15
16978669290005Astrasono A3Pro Bladder ScannerA3Pro2025-11-20

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