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Falcon/Quad

by Viasonix Ltd.

Ref PVC0078Model Falcon – Vascular diagnostic systems

Falcon/Quad (PVC0078) is a general-purpose ultrasound imaging system (EU MDR Class IIa; FDA Class II; FDA product code JOP, Transducer, Ultrasonic) made by Viasonix Ltd, registered in EUDAMED on 2 Sep 2025 (Basic UDI-DI 729001688033CG) with CE/MDR certificate 3903018CE01 valid until 1 Jan 2028, cleared under FDA 510(k) K111416 on 15 Jul 2011 and listed in FDA GUDID since 21 Nov 2016 (UDI-DI 07290016880014), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

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) K111416↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729001688033CG Basic UDI-DI 07290016880014UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016880014 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK111416 Date15 Jul 2011IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729001688033CG registered 2 Sep 2025 Active· +1 more in the status table
  • FDA 510(k) K111416 decided 15 Jul 2011 Active
  • FDA GUDID UDI-DI 07290016880014 listed 21 Nov 2016 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) K111416
  2. Listed FDA GUDID 07290016880014
  3. Certificate issued EUDAMED 3903018CE01
  4. Registered EUDAMED 729001688033CG
  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  • Withdrawn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 · 510(k) · GUDID

Trade name
Falcon/Quad EUDAMED
Falcon GUDID
Generic name
General-purpose ultrasound imaging system
Device name
Falcon/Pro
Model / Ref / Catalog
Falcon – Vascular diagnostic systems, PVC0078, Quad
Primary DI / UDI-DI
07290016880014
Basic UDI-DI
729001688033CG
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
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Falcon – Vascular diagnostic systems
PVC0078
GUDID
Quad
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

See all devices from Viasonix Ltd →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)