ClearanceBrief
Company ยท GB

Ultromics Limited

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2024. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
QIHAutomated Radiological Image Processing Software2
QUOAdjunctive Heart Failure Status Indicator2
POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
SDJAdjunctive Cardiac Amyloidosis Status Indicator1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 15, 2024K240860EchoGo Amyloidosis (1.0)
Ultromics Limited, GB
SDJ
Sep 23, 2024K240013EchoGo Heart Failure (2.0)
Ultromics Limited, GB
QUO
Nov 23, 2022K222463EchoGo Heart Failure
Ultromics Limited, GB
QUO
Dec 20, 2021K213275EchoGo Core (2.0)
Ultromics Limited, GB
QIH
Dec 18, 2020K201555EchoGo Pro
Ultromics, Ltd., GB
POK
Nov 13, 2019K191171EchoGo Core
Ultromics, Ltd., GB
QIH

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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