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BladderScan® i10™

by Verathon Inc 3 variants

Ref 0620-1083

BladderScan i10 (0620-1083) is an ultrasound system quality assurance device (EU MDR Class I; FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Verathon Inc, registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0879123000015X4), cleared under FDA 510(k) K172356 on 15 Sep 2017 and listed in FDA GUDID since 21 May 2021 (UDI-DI 00879123008145), active as of 8 Nov 2026.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172356

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0879123000015X4 Basic UDI-DI 00879123008145UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123008145 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172356 Date15 Sep 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0879123000015X4 registered 28 Oct 2026 Active
  • FDA 510(k) K172356 decided 15 Sep 2017 Active
  • FDA GUDID UDI-DI 00879123008145 listed 21 May 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-0531-2021 FDA Class II initiated 29 Sep 2020 on shared 510(k) K172356

    Due to a change in handle material and process, probe handle may crack.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K172356
  2. Recall initiated FDA recalls Z-0531-2021
  3. Listed FDA GUDID 00879123008145
  4. Registered EUDAMED 0879123000015X4

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  • Withdrawn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 · GUDID

Trade name
BladderScan Calibration Tank EUDAMED
BladderScan® GUDID
Generic name
Ultrasound system quality assurance device
Device name
Calibration Equipment
Model / Ref / Catalog
0620-1083, i10™
Primary DI / UDI-DI
00879123008145
Basic UDI-DI
0879123000015X4
510(k) Number
FDA product code
IYO
EMDN code
V0399 Measurement devices - other
GMDN term
Ultrasound system quality assurance device
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0620-1083
GUDID
i10™
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Ultrasound system quality assurance device

Cleared under the same submission (K172356)

and 4 more cleared under K172356

Similar devices in this category

Other devices filed under MEASUREMENT DEVICES - OTHER.

Other devices from Verathon Inc

See all devices from Verathon Inc →

Properties

  • Manufacturing date
Other properties (24, all answered No)