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Falcon/ABI+

by Viasonix Ltd.

Ref PVC0079Model Falcon – Vascular diagnostic systems

Falcon/ABI+ (PVC0079) 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 07290016880021), active as of 22 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 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

510(k) K111416

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729001688033CG Basic UDI-DI 07290016880021UDI-DIDate2 Sep 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016880021 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: 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 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 07290016880021 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 07290016880021
  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  • Withdrawn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 · GUDID

Trade name
Falcon/ABI+ EUDAMED
Falcon GUDID
Generic name
General-purpose ultrasound imaging system
Device name
Falcon/Pro
Model / Ref / Catalog
Falcon – Vascular diagnostic systems, PVC0079, ABI+
Primary DI / UDI-DI
07290016880021
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
PVC0079
GUDID
ABI+
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

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