SIGMA

System, X-ray, Extraoral Source, Digital

INSTRUMENTARIUM IMAGING, INC.

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

Pre-market Notification Details

• Device ID: K001928
• 510k Number: K001928
• Device Name: SIGMA
• Classification: System, X-ray, Extraoral Source, Digital
• Applicant: INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025
• Contact: Doug Woods
• Correspondent: Doug Woods; INSTRUMENTARIUM IMAGING, INC. 300 WEST EDGERTON AVE. Milwaukee, WI 53207 -6025
• Product Code: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-06-26
• Decision Date: 2000-08-02