STAGE

System, Nuclear Magnetic Resonance Imaging

SpinTech, Inc.

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

Pre-market Notification Details

• Device ID: K210843
• 510k Number: K210843
• Device Name: STAGE
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: SpinTech, Inc. 30200 Telegraph Road, Suite 140 Bingham Farms, MI 48025
• Contact: Kay Fuller
• Correspondent: Prithul Bom; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2021-03-22
• Decision Date: 2021-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00866463000410	K210843	000