HeartLab
Intended Use

United Kingdom

HeartLab is intended for use by trained healthcare professionals only.

HeartLab Core

HeartLab Core is intended to be used by qualified healthcare professionals for the storage, retrieval, display, and reporting of medical imaging data. The software provides measurement tools that enable clinicians to perform their own measurements on medical images. The software does not provide diagnostic information, automated analysis, or clinical decision support; all clinical interpretation is performed by the clinician.

Indications for Use

HeartLab Core is indicated for use in hospital and clinical settings for adult and paediatric patients undergoing medical imaging examination.

MFR
Manufacturer
HeartLab Limited 305 / 150 Karangahape Road Auckland 1010 New Zealand
UK REP
UK Responsible Person
Casus UKRP Ltd 107-111 Fleet Street London EC4A 2AB United Kingdom
AUS
Australian Sponsor
Emergo Australia Level 20 Tower II Darling Park 201 Sussex Street Sydney NSW 2000 Australia
MD Applies to HeartLab v7.2 and above Effective 0000-00-00 eIFU version 0.0.0 UDI-DI 09421907090023