Skip to content

10MC3 Transducer 11268679

by Siemens Medical Solutions USA, Inc.

Ref 11268679Model MDR_07_IIA_IQH_BTS LB A_ACDV_10MC3_11268679

10MC3 Transducer 11268679 is a device classified as Class IIa in the EU and Class II in the US made by Siemens Medical Solutions USA, Inc., registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 0405686902416VL), cleared under FDA 510(k) K232617 on 26 Sep 2023 (2 earlier submissions) and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 04056869059167), active as of 23 Oct 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

5 ongoing

Recall on shared 510(k) K232617, K201130; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232617

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0405686902416VL Basic UDI-DI 04056869059167UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK232617 Date26 Sep 2023DecidedStatusActive
United StatesGUDID listing GUDID Number04056869059167 UDI-DI Date12 Mar 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686902416VL registered 8 Sep 2026 Active
  • FDA 510(k) K232617 decided 26 Sep 2023 Active· +2 more in the status table
  • FDA GUDID UDI-DI 04056869059167 listed 12 Mar 2018 Listed

Recalls

6 recalls · 5 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-3217-2024 FDA Class II initiated 15 Aug 2024 on shared 510(k) K232617
    • Ongoing Z-3215-2024 FDA Class II initiated 15 Aug 2024 on shared 510(k) K201130

    If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

  • 2 recalls, same reason

    • Ongoing Z-1599-2024 FDA Class II initiated 23 Feb 2024 on shared 510(k) K201130
    • Ongoing Z-1601-2024 FDA Class II initiated 23 Feb 2024 on shared 510(k) K232617

    On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

    • Ongoing Z-0748-2022 FDA Class II initiated 19 Jan 2022 on shared 510(k) K201130

    The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.

    • Terminated Z-2471-2021 FDA Class II initiated 12 Jul 2021 on shared 510(k) K201130

    Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

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

Timeline

11 dated events

  1. Listed FDA GUDID 04056869059167
  2. Cleared FDA 510(k) K201130
  3. Recall initiated FDA recalls Z-2471-2021
  4. Recall initiated FDA recalls Z-0748-2022
  5. Cleared FDA 510(k) K232617
  6. Recall initiated FDA recalls Z-1599-2024
  7. Recall initiated FDA recalls Z-1601-2024
  8. Recall initiated FDA recalls Z-3217-2024
  9. Recall initiated FDA recalls Z-3215-2024
  10. Registered EUDAMED 0405686902416VL

1 earlier event are in the sections above.

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
10MC3 Transducer
Generic name
Rectal/vaginal ultrasound imaging transducer
Device name
MDR_07_IIA_IQH_BTS Lb A_ACDV_10MC3_11268679
Model / reference
11268679, MDR_07_IIA_IQH_BTS LB A_ACDV_10MC3_11268679
Primary DI / UDI-DI
04056869059167
Basic UDI-DI
0405686902416VL
510(k) Number
FDA product code
ITX
EMDN code
Z1104020201 Endocavitary ultrasound probes, two–dimensional
GMDN term
Rectal/vaginal ultrasound imaging transducer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
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 GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Rectal/vaginal ultrasound imaging transducer

Cleared under the same submission (K180039)

and 8 more cleared under K180039

Cleared under the same submission (K201130)

and 8 more cleared under K201130

Similar devices in this category

Other devices filed under ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL.

Other devices from Siemens Medical Solutions USA, Inc.

See all devices from Siemens Medical Solutions USA, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)