Devices · NICo-Lab B.V.

HALO

NICo-Lab B.V. is listed for HALO (K200873). The FDA list gives November 20, 2020 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QAS as “Radiological Computer-Assisted Triage And Notification Software”: Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification . openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200873

Official FDA database record

Date of final decision

November 20, 2020

Company on the FDA list

NICo-Lab B.V.

Lead panel

Radiology

Primary product code

QAS

openFDA device name for the code

Radiological Computer-Assisted Triage And Notification Software

Device class

2

Regulation number

892.2080

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary