PEDCAT

System, X-ray, Tomography, Computed

CURVEBEAM, LLC

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

Pre-market Notification Details

• Device ID: K113548
• 510k Number: K113548
• Device Name: PEDCAT
• Classification: System, X-ray, Tomography, Computed
• Applicant: CURVEBEAM, LLC 175 TITUS AVE SUITE 300 Warrington, PA 18976
• Contact: David W Cowan
• Correspondent: David W Cowan; CURVEBEAM, LLC 175 TITUS AVE SUITE 300 Warrington, PA 18976
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-01
• Decision Date: 2012-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00863152000317	K113548	000
00863152000300	K113548	000