Skip to content

8 MHz probe

by Viasonix Ltd 2 variants

Ref PVC0331Model Ultrasonic transducer

8 MHz probe (PVC0331), a general-purpose ultrasound imaging system (EU MDR Class IIa; FDA Class II; FDA product code JOP, Transducer, Ultrasonic) made by Viasonix Ltd, was registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 729001688037CQ), cleared under FDA 510(k) K111416 on 15 Jul 2011 and listed in FDA GUDID on 8 Aug 2022 (UDI-DI 07290016880403); the registry lists it as 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

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111416

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 Number729001688037CQ Basic UDI-DI 07290016880403UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016880403 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK111416 Date15 Jul 2011IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001688037CQ registered 17 Aug 2026 Active
  • FDA 510(k) K111416 decided 15 Jul 2011 Active
  • FDA GUDID UDI-DI 07290016880403 listed 8 Aug 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111416
  2. Listed FDA GUDID 07290016880403
  3. Registered EUDAMED 729001688037CQ

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  • Withdrawn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
Viasonix 8MHz probe EUDAMED
8 MHz probe GUDID
Generic name
General-purpose ultrasound imaging system
Device name
Probes
Model / Ref / Catalog
Ultrasonic transducer, PVC0331, 8 MHz probe
Primary DI / UDI-DI
07290016880403
Basic UDI-DI
729001688037CQ
510(k) Number
FDA product code
JOP
EMDN code
Z11040103 Portable ultrasound scanners
GMDN term
General-purpose ultrasound imaging system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2880
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Ultrasonic transducer
PVC0331
GUDID
8 MHz probe
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: General-purpose ultrasound imaging system

Cleared under the same submission (K111416)

and 3 more cleared under K111416

Similar devices in this category

Other devices filed under PORTABLE ULTRASOUND SCANNERS.

Other devices from Viasonix Ltd

See all devices from Viasonix Ltd →

Properties

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