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Dolphin 4D

by Viasonix Ltd

Dolphin 4D, a general-purpose ultrasound imaging system (FDA Class II) made by Viasonix Ltd, was cleared under FDA 510(k) K170859 on 14 Nov 2017 and listed in FDA GUDID on 17 Dec 2017 (UDI-DI 07290016880038); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170859

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016880038 UDI-DI Date17 Dec 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170859 Date14 Nov 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170859 decided 14 Nov 2017 Active
  • FDA GUDID UDI-DI 07290016880038 listed 17 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170859
  2. Listed FDA GUDID 07290016880038

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dolphin
Generic name
General-purpose ultrasound imaging system
Model / reference
4D
Primary DI / UDI-DI
07290016880038
510(k) Number
FDA product code
IYN, ITX
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1550, 892.1570
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Other devices from Viasonix Ltd

See all devices from Viasonix Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)