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: K223079
• 510k Number: K223079
• Device Name: Stage
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms, MI 48025
• Contact: Rana El Hachem
• Correspondent: Rana El Hachem; SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms, MI 48025
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-09-30
• Decision Date: 2022-10-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00866463000441	K223079	000
00866463000465	K223079	000