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Dolphin/4D

by Viasonix Ltd.

Ref PVC0201Model Dolphin product family – Transcranial Doppler systems

Dolphin/4D (PVC0201) is a general-purpose ultrasound imaging system (EU MDR Class IIa; FDA Class II) made by Viasonix Ltd, registered in EUDAMED on 3 Sep 2025 (Basic UDI-DI 729001688034CJ) with CE/MDR certificate 3903018CE01 valid until 1 Jan 2028, cleared under FDA 510(k) K191023 on 16 May 2019 and listed in FDA GUDID since 7 Jun 2019 (UDI-DI 07290016880311), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDR 510(k)

Valid until

1 Jan 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K191023

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 Number729001688034CJ Basic UDI-DI 07290016880311UDI-DIDate3 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016880311 UDI-DI Date7 Jun 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK191023 Date16 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001688034CJ registered 3 Sep 2025 Active· +1 more in the status table
  • FDA 510(k) K191023 decided 16 May 2019 Active
  • FDA GUDID UDI-DI 07290016880311 listed 7 Jun 2019 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3903018CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    23 Jun 2025
    Expires
    1 Jan 2028
    Reason
    Mnf data change

Timeline

5 dated events

  1. Cleared FDA 510(k) K191023
  2. Listed FDA GUDID 07290016880311
  3. Certificate issued EUDAMED 3903018CE01
  4. Registered EUDAMED 729001688034CJ
  5. Certificate expires EUDAMED 3903018CE01

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
Dolphin/4D EUDAMED
Dolphin GUDID
Generic name
General-purpose ultrasound imaging system
Device name
Dolphin/IQ
Model / reference
Dolphin product family – Transcranial Doppler systems EUDAMED
PVC0201 EUDAMED
4D GUDID
Primary DI / UDI-DI
07290016880311
Basic UDI-DI
729001688034CJ
510(k) Number
FDA product code
ITX, IYN
EMDN code
Z11040103 Portable ultrasound scanners
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1550
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Dolphin product family – Transcranial Doppler systems
PVC0201
GUDID
4D
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.

Manufacturer details

EUDAMED SRN
IL-MF-000021015
Authorised representative
Arazy Group GmbH DE-AR-000007685

Similar devices in this category

Other devices filed under PORTABLE ULTRASOUND SCANNERS.

Other devices from Viasonix Ltd

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)