EchoGo Core 2.0

by Ultromics, Ltd.

EchoGo Core 2.0 is a Class II device made by Ultromics, Ltd., cleared under FDA 510(k) K213275 on 20 Dec 2021 and listed in FDA GUDID since 19 Jan 2022 (UDI-DI 05060634690027), 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	Number05060634690027 UDI-DI	Date19 Jan 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213275	Date20 Dec 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05060634690027
FDA 510(k) database 510(k) number K213275

Across registries

2 registries list this device

FDA 510(k) K213275 decided 20 Dec 2021 Active
FDA GUDID UDI-DI 05060634690027 listed 19 Jan 2022 Listed

Timeline

2 dated events

20 Dec 2021 Cleared FDA 510(k) K213275
19 Jan 2022 Listed FDA GUDID 05060634690027

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Withdrawn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: Core 2.0

Primary DI / UDI-DI: 05060634690027
510(k) Number: K213275
FDA product code: QIH
GMDN term: Radiology DICOM image processing application software

Device class: Class II
Regulation number: 892.2050
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Manufacturing date

Other properties (12, all answered No)