IMAGEQUBE

System, Image Processing, Radiological

INTUITIVE IMAGING INFORMATICS, LLC

The following data is part of a premarket notification filed by Intuitive Imaging Informatics, Llc with the FDA for Imageqube.

Pre-market Notification Details

• Device ID: K124048
• 510k Number: K124048
• Device Name: IMAGEQUBE
• Classification: System, Image Processing, Radiological
• Applicant: INTUITIVE IMAGING INFORMATICS, LLC 30 Hackamore Ln Ste 6 Bell Canyon, CA 91307
• Contact: Cindy Simoni
• Correspondent: Jeff D Rongero; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-12-31
• Decision Date: 2013-01-29
• Summary: summary