EchoGo Pro

by Ultromics, Ltd.

EchoGo Pro is a Class II device made by Ultromics, Ltd., cleared under FDA 510(k) K201555 on 18 Dec 2020 and listed in FDA GUDID since 5 Feb 2021 (UDI-DI 05060634690010), 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	Number05060634690010 UDI-DI	Date5 Feb 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK201555	Date18 Dec 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060634690010
FDA 510(k) database 510(k) number K201555

Across registries

2 registries list this device

FDA 510(k) K201555 decided 18 Dec 2020 Active
FDA GUDID UDI-DI 05060634690010 listed 5 Feb 2021 Listed

Timeline

2 dated events

18 Dec 2020 Cleared FDA 510(k) K201555
5 Feb 2021 Listed FDA GUDID 05060634690010

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EchoGo
Generic name: Ultrasound imaging system application software
Model / reference: Pro

Primary DI / UDI-DI: 05060634690010
510(k) Number: K201555
FDA product code: POK
GMDN term: Ultrasound imaging system application software

Device class: Class II
Regulation number: 892.2060
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)