TruPlan

System, Image Processing, Radiological

Circle Cardiovascular Imaging Inc.

The following data is part of a premarket notification filed by Circle Cardiovascular Imaging Inc. with the FDA for Truplan.

Pre-market Notification Details

• Device ID: K202212
• 510k Number: K202212
• Device Name: TruPlan
• Classification: System, Image Processing, Radiological
• Applicant: Circle Cardiovascular Imaging Inc. Suite 1100-800 5th Ave SW Calgary, CA T2p 3t6
• Contact: Shirantha Samarappuli
• Correspondent: Shirantha Samarappuli; Circle Cardiovascular Imaging Inc. Suite 1100-800 5th Ave SW Calgary, CA T2p 3t6
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-06
• Decision Date: 2021-02-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00882916000516	K202212	000
00882916000523	K202212	000