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Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

by Avantsonic Technology Co., Ltd.

510(k) K171528Ref Bladder scanner/AS-2, Bladder scanner/Z5, Bladder scanner/Z3Model AS-2, Z5, Z3

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230986

+1 more

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697175981003NP Basic UDI-DI Date28 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230986 Date29 Dec 2023DecidedStatusActive
United StatesGUDID listing GUDID Number06971759810025 UDI-DI Date10 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK171528 Date24 Jan 2018ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697175981003NP registered 28 May 2026 Active
  • FDA 510(k) K230986 decided 29 Dec 2023 Active· +1 more in the status table
  • FDA GUDID UDI-DI 06971759810025 listed 10 Jul 2018 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K171528
  2. Listed FDA GUDID 06971759810025
  3. Cleared FDA 510(k) K230986
  4. Registered EUDAMED 697175981003NP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
Bladder scanner EUDAMED
AvantSonic GUDID
Generic name
Bladder volume ultrasound imaging system
Model / reference
Z3, Z5, AS-2, Bladder scanner/AS-2, Bladder scanner/Z5, Bladder scanner/Z3
Primary DI / UDI-DI
06971759810025, 06971759810018, 06971759810032
Basic UDI-DI
697175981003NP, 69717598106971759810018YQ, 69717598106971759810025YM
Direct marketing DI
06971759810032
06971759810018
06971759810025
510(k) Number
FDA product code
IYO
EMDN code
Z12080304 Ultrasonic bladder volume scanners
GMDN term
Bladder volume ultrasound imaging system
Device class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1560
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K171528

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K171528
UDI-DISize and differences
AvantSonic Z3
Avantsonic Technology Co., Ltd.
Z306971759810025 —On the market
AvantSonic Z5
Avantsonic Technology Co., Ltd.
Z506971759810018 —On the market

Similar devices in this category

Other devices filed under ULTRASONIC BLADDER VOLUME SCANNERS.

Other devices from Avantsonic Technology Co., Ltd.

  • Avantsonic As-1

    Class II

  • Bladder Scanner

    Class II

Properties

  • Reusable YesEUDAMEDNoEUDAMED
  • Measuring function
  • Prescription use NoGUDIDYesGUDID
  • Serial number
  • Expiration date NoGUDIDYesGUDID
  • Manufacturing date
Other properties (19, all answered No)