LineUp

System, X-ray, Tomography, Computed

CurveBeam, LLC

The following data is part of a premarket notification filed by Curvebeam, Llc with the FDA for Lineup.

Pre-market Notification Details

• Device ID: K180727
• 510k Number: K180727
• Device Name: LineUp
• Classification: System, X-ray, Tomography, Computed
• Applicant: CurveBeam, LLC 175 Titus Ave Suite 300 Warrington, PA 18976
• Contact: Stuti Singh
• Correspondent: Dave Yungvirt; THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2018-03-20
• Decision Date: 2018-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00863152000355	K180727	000
00863152000348	K180727	000