EchoGo Heart Failure 2.0

by Ultromics, Ltd.

EchoGo Heart Failure 2.0 is a Class II device made by Ultromics, Ltd., cleared under FDA 510(k) K240013 on 23 Sep 2024 and listed in FDA GUDID since 17 Dec 2024 (UDI-DI 05060634690058), 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	Number05060634690058 UDI-DI	Date17 Dec 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK240013	Date23 Sep 2024Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060634690058
FDA 510(k) database 510(k) number K240013

Across registries

2 registries list this device

FDA 510(k) K240013 decided 23 Sep 2024 Active
FDA GUDID UDI-DI 05060634690058 listed 17 Dec 2024 Listed

Timeline

2 dated events

23 Sep 2024 Cleared FDA 510(k) K240013
17 Dec 2024 Listed FDA GUDID 05060634690058

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EchoGo
Generic name: Radiology DICOM image processing application software
Model / reference: Heart Failure 2.0

Primary DI / UDI-DI: 05060634690058
510(k) Number: K240013
FDA product code: QUO
GMDN term: Radiology DICOM image processing application software

Device class: Class II
Regulation number: 870.2200
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)