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Bladder Scanner - model: PadScan DS3

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K171528Ref Bladder scanner/AS-2Model AS-2Ref Bladder scanner/Z5Model Z5Ref Bladder scanner/Z3Model Z3

by Avantsonic Technology Co., Ltd.

Identity

Trade Name
Bladder scanner EUDAMED
AvantSonic FDA UDI
Generic Name
Bladder volume ultrasound imaging system FDA UDI
Device Name
Bladder Scanner EUDAMED
Model / Reference
Z3 EUDAMEDFDA UDI
Z5 EUDAMEDFDA UDI
AS-2 EUDAMEDFDA UDI
Bladder scanner/AS-2 EUDAMED
Bladder scanner/Z5 EUDAMED
Bladder scanner/Z3 EUDAMED

Identifiers

Primary DI / UDI-DI
06971759810025 EUDAMEDFDA UDI
06971759810018 EUDAMEDFDA UDI
06971759810032 EUDAMEDFDA UDI
Basic UDI-DI
697175981003NP EUDAMED
69717598106971759810018YQ EUDAMED
69717598106971759810025YM EUDAMED
Direct Marketing DI
06971759810032 EUDAMED
06971759810018 EUDAMED
06971759810025 EUDAMED
510(k) Number
K171528 FDA 510(k)FDA UDI
K230986 FDA UDI
FDA Product Code
IYO FDA 510(k)FDA UDI
EMDN Code
Z12080304 ULTRASONIC BLADDER VOLUME SCANNERS EUDAMED
GMDN Term
Bladder volume ultrasound imaging system FDA UDI
Models / Variants
model: PadScan DS3 FDA 510(k)FDA UDIEUDAMED
PadScan Z3 FDA 510(k)FDA UDIEUDAMED
PadScan Z5 FDA 510(k)FDA UDIEUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)FDA UDI
Market of Registration
France EUDAMED
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMEDEUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDI

The PadScan DS3, PadScan Z3, and PadScan Z5 are portable ultrasound-based bladder scanners designed to measure bladder volume noninvasively. These devices project ultrasound energy through the lower abdomen to generate images of the bladder, enabling accurate volume calculations without invasive procedures. Classified under the nomenclature for diagnostic ultrasound systems, they are intended for use in clinical settings where bladder assessment is required.

These scanners are supplied as reusable medical devices and are intended for use by qualified medical professionals. The PadScan models operate in non-sterile environments and are not MRI-compatible. Each model (DS3, Z3, Z5) may vary in design features such as ergonomics and stability, but all adhere to regulatory standards including FDA 510(k) clearance and MDR compliance. Storage and handling follow standard medical device protocols as specified by the manufacturer.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5), AvantSonic Technology Co., Ltd., Bladder scanner-AvantSonic Technology Co., Ltd., Avantsonic Technology Co., Ltd. FDA 510 (k) Products 2023

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avantsonic Technology Co., Ltd.

Sources (7)

  • FDA 510(k) K171528 24 fields · synced Sep 18, 2026
  • FDA UDI 2fb48420-da18-48b9-b7cd-dd6ea18c395d 33 fields · synced May 30, 2026
  • FDA UDI 1ed9e8a7-b69c-4a52-bebd-3f42b6c08dc3 33 fields · synced May 30, 2026
  • FDA UDI 1491467d-30cb-4510-bcc3-9c5629b04416 33 fields · synced May 30, 2026
  • EUDAMED f046b165-c709-46de-8091-d76e6d86e85d 61 fields · synced Jul 9, 2026
  • EUDAMED d9b9a852-fcef-4d70-9a9b-6c1bed6a60f7 61 fields · synced Jul 12, 2026
  • EUDAMED 2c587fcd-204c-40fe-be05-ec391feae716 61 fields · synced Jul 13, 2026