ECHOSYSTEM

System, Image Processing, Radiological

MEDSTRAT, INC.

The following data is part of a premarket notification filed by Medstrat, Inc. with the FDA for Echosystem.

Pre-market Notification Details

• Device ID: K051745
• 510k Number: K051745
• Device Name: ECHOSYSTEM
• Classification: System, Image Processing, Radiological
• Applicant: MEDSTRAT, INC. 1901 BUTTERFIELD RD. SUITE 600 Downers Grove, IL 60515
• Contact: Robert J Bishop
• Correspondent: Silvia Ankova; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-06-29
• Decision Date: 2005-07-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817886020578	K051745	000
00817886020417	K051745	000
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