HALO

Radiological Computer-assisted Triage And Notification Software

NICo-Lab B.V.

The following data is part of a premarket notification filed by Nico-lab B.v. with the FDA for Halo.

Pre-market Notification Details

• Device ID: K200873
• 510k Number: K200873
• Device Name: HALO
• Classification: Radiological Computer-assisted Triage And Notification Software
• Applicant: NICo-Lab B.V. Paasheuvelweg 25 Amsterdam, NL 1105bp
• Contact: Merel Boers
• Correspondent: Roujuan Zhang; MD Squared B.V. High Tech Campus 29 Eindhoven, NL 5858ae
• Product Code: QAS
• CFR Regulation Number: 892.2080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-04-01
• Decision Date: 2020-11-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08720299502338	K200873	000