ResolutionMD

System, Image Processing, Radiological

CALGARY SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Calgary Scientific, Inc. with the FDA for Resolutionmd.

Pre-market Notification Details

• Device ID: K161130
• 510k Number: K161130
• Device Name: ResolutionMD
• Classification: System, Image Processing, Radiological
• Applicant: CALGARY SCIENTIFIC, INC. SUITE 208, 1210- 20TH AVENUE SE Calgary, CA T2g 1m8
• Contact: Kyle Peterson
• Correspondent: Kyle Peterson; CALGARY SCIENTIFIC, INC. SUITE 208, 1210- 20TH AVENUE SE Calgary, CA T2g 1m8
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-21
• Decision Date: 2016-08-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
17540262040012	K161130	000
17540262040029	K161130	000