Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017210169

FEI Number

3017210169

Entity Name

BRAINOMIX LIMITED

City/State/Country

Oxford Oxfordshire, GB

Establishment Address

First Floor, Seacourt tower, West Way, Oxford Oxfordshire OX2 0JJ, GB

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Brainomix Limited (Owner Number: 10076467)

Owner / Operator Contact Address

First Floor, Seacourt Tower, West Way, Oxford, GB-OXF OX2 0JJ, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242123

PMA Number

N/A

All Registered Proprietary Names

Brainomix 360 e-ASPECTS e-ASPECTS Triage Stroke Brainomix 360 Triage Stroke Brainomix 360 e-CTP e-CTP Brainomix 360 e-Lung e-Lung e-ASPECTS Brainomix 360 e-ASPECTS e-Lung Brainomix 360 e-Lung Triage Stroke Brainomix 360 Triage Stroke Brainomix 360 e-MRI e-MRI Brainomix 360 e-CTA e-CTA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2025-03-11
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-11-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-06-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-06-06
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2023-03-06
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2025-03-11
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-11-22
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-08-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-03-11
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-03-11

Official Correspondent

Zsolt Szrnka

US Agent Details

Shilpa Gampa Business: FREYR INC Email: usagent@freyrsolutions.com Phone: (760) 5834401

Related Public Records

Same Entity

Brainomix Limited

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
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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2518586	Philips Ultrasound LLC	Reedsville, PA, US
3040335643	AISAP LTD	Ramat Gan Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017210169. Last updated year: 2026. Please use registration number 3017210169 when referencing this establishment in official correspondence.