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Linear Probe L18-4 A7C8

by Konica Minolta, Inc.

Ref L18-4Model LINEAR PROBE L18-4

Linear Probe L18-4 A7C8 is an extracorporeal ultrasound imaging transducer (EU MDR Class IIa; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Konica Minolta, Inc., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 4560141920000578N), cleared under FDA 510(k) K142197 on 21 Nov 2014 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 04560141940161), active as of 24 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

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142197

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4560141920000578N Basic UDI-DI 04560141940161UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04560141940161 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142197 Date21 Nov 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4560141920000578N registered 2 Jul 2026 Active
  • FDA 510(k) K142197 decided 21 Nov 2014 Active
  • FDA GUDID UDI-DI 04560141940161 listed 19 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-1212-2018 FDA Class II initiated 4 Dec 2017 on shared 510(k) K142197

    There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

    • Terminated Z-2769-2017 FDA Class II initiated 24 Apr 2017 on shared 510(k) K142197

    The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K142197
  2. Listed FDA GUDID 04560141940161
  3. Recall initiated FDA recalls Z-2769-2017
  4. Recall initiated FDA recalls Z-1212-2018
  5. Registered EUDAMED 4560141920000578N

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
Linear Probe L18-4
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
LINEAR PROBE L18-4 EUDAMED
L18-4 EUDAMED
A7C8 GUDID
Primary DI / UDI-DI
04560141940161
Basic UDI-DI
4560141920000578N
Direct marketing DI
04560141940161
510(k) Number
FDA product code
ITX
EMDN code
Z110402010101 Two–dimensional linear–array transcutaneous ultrasound probes
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
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
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LINEAR PROBE L18-4
L18-4
GUDID
A7C8
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: Extracorporeal ultrasound imaging transducer, hand-held

Cleared under the same submission (K142197)

Similar devices in this category

Other devices filed under TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES.

Other devices from Konica Minolta, Inc.

See all devices from Konica Minolta, Inc. →

Properties

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