LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE

Primary DI

+G26420

Basic UDI-DI Code

++G264HALOAPXN

Reference

HALO AP

Device Types

New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Indica Labs

HALO AP™ is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an assistance tool for displaying images to a pathologist. The pathologist then reviews and interprets the images prior to rendering a primary diagnosis. HALO AP is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. HALO AP is intended for use with supported scanner images and monitor displays validated with test methods verified to meet required performance specifications. Pathologists should only use HALO AP in conjunction with their complete standard of care evaluation of the whole slide image.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).