Dopplex IOP8-Usa

by Huntleigh Healthcare, Ltd.

Dopplex IOP8-Usa is a Class II device made by Huntleigh Healthcare, Ltd., cleared under FDA 510(k) K032315 on 18 Nov 2004 and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 05051968020161), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05051968020161 UDI-DI	Date22 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK032315	Date18 Nov 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05051968020161
FDA 510(k) database 510(k) number K032315

Across registries

2 registries list this device

FDA 510(k) K032315 decided 18 Nov 2004 Active
FDA GUDID UDI-DI 05051968020161 listed 22 Aug 2016 Listed

Timeline

2 dated events

18 Nov 2004 Cleared FDA 510(k) K032315
22 Aug 2016 Listed FDA GUDID 05051968020161

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Dopplex
Generic name: Invasive vascular ultrasound system probe
Model / Ref / Catalog: IOP8-USA

Primary DI / UDI-DI: 05051968020161
510(k) Number: K032315
FDA product code: ITX
GMDN term: Invasive vascular ultrasound system probe

Device class: Class II
Regulation number: 892.1570
GUDID distribution status: In Commercial Distribution

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Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11, all answered No)