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Disk PPG sensor

by Viasonix Ltd

Ref PVC0076Model PPG

Disk PPG sensor, 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 14 Aug 2026 (Basic UDI-DI 729001688036CN), cleared under FDA 510(k) K111416 on 15 Jul 2011 and listed in FDA GUDID on 19 Jun 2020 (UDI-DI 07290016880175); the registry lists it as not in commercial distribution (GUDID) as of 22 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 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729001688036CN Basic UDI-DI 07290016880175UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016880175 UDI-DI Date19 Jun 2020ListedStatusListed 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 729001688036CN registered 14 Aug 2026 Active
  • FDA 510(k) K111416 decided 15 Jul 2011 Active
  • FDA GUDID UDI-DI 07290016880175 listed 19 Jun 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111416
  2. Listed FDA GUDID 07290016880175
  3. Registered EUDAMED 729001688036CN

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  • Withdrawn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
PPG Disk sensors (Green, Red) EUDAMED
Disk PPG sensor GUDID
Generic name
General-purpose ultrasound imaging system
Device name
PPG Toe Clip sensors
Model / reference
PPG EUDAMED
PVC0076 EUDAMED
Disk PPG sensor GUDID
Primary DI / UDI-DI
07290016880175
Basic UDI-DI
729001688036CN
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
PPG
PVC0076
GUDID
Disk PPG sensor
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

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)