ORTHONE

System, Nuclear Magnetic Resonance Imaging

ONI, INC.

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

Pre-market Notification Details

• Device ID: K001773
• 510k Number: K001773
• Device Name: ORTHONE
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: ONI, INC. 790 TURNPIKE STREET, STE 100 North Andover, MA 01845
• Contact: Michael A Douglas
• Correspondent: Michael A Douglas; ONI, INC. 790 TURNPIKE STREET, STE 100 North Andover, MA 01845
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-12
• Decision Date: 2000-08-18