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: K211788
• 510k Number: K211788
• Device Name: HALO
• Classification: Radiological Computer-assisted Triage And Notification Software
• Applicant: Nico.Lab B.V. Paasheuvelweg 25 Amsterdam, NL 1105 Bp
• Contact: Merel Boers
• Correspondent: Ruojuan Zhang; MD Squared B.V. High Tech Campus 29 Eindhoven, NL 5656 Ae
• Product Code: QAS
• CFR Regulation Number: 892.2080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-09
• Decision Date: 2021-07-08