Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016585383

FEI Number

3016585383

Entity Name

ULTROMICS, LTD.

City/State/Country

Oxford Oxfordshire, GB

Establishment Address

4630 Kingsgate, Cascade Way, Oxford Business Park South, Oxford Oxfordshire OX4 2SU, GB

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Ultromics, Ltd. (Owner Number: 10062539)

Owner / Operator Contact Address

4630 Kingsgate, Cascade Way, Oxford Business Park South, Oxford, GB-OXF OX4 2SU, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240013

PMA Number

N/A

All Registered Proprietary Names

EchoGo Core EchoGo Core EchoGo Pro EchoGo Heart Failure (2)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2021-12-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2020-02-11
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2021-02-03
QUO	Adjunctive Heart Failure Status Indicator	Cardiovascular	Class 2	870.2200	2024-12-10

Official Correspondent

Jaco Jacobs

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Ultromics, Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016585383. Last updated year: 2026. Please use registration number 3016585383 when referencing this establishment in official correspondence.