AURORA

System, Nuclear Magnetic Resonance Imaging

AURORA IMAGING TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Aurora Imaging Technology, Inc. with the FDA for Aurora.

Pre-market Notification Details

• Device ID: K032082
• 510k Number: K032082
• Device Name: AURORA
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: AURORA IMAGING TECHNOLOGY, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Contact: James R Veale
• Correspondent: James R Veale; AURORA IMAGING TECHNOLOGY, INC. 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-07
• Decision Date: 2003-07-30
• Summary: summary