MOBIVISION

Solid State X-ray Imager (flat Panel/digital Imager)

ALMANA MEDICAL IMAGING

The following data is part of a premarket notification filed by Almana Medical Imaging with the FDA for Mobivision.

Pre-market Notification Details

• Device ID: K100001
• 510k Number: K100001
• Device Name: MOBIVISION
• Classification: Solid State X-ray Imager (flat Panel/digital Imager)
• Applicant: ALMANA MEDICAL IMAGING 8726 FERRARA CT Naples, FL 34114
• Contact: Daniel Kamm, P.e.
• Correspondent: Daniel Kamm, P.e.; ALMANA MEDICAL IMAGING 8726 FERRARA CT Naples, FL 34114
• Product Code: MQB
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-04
• Decision Date: 2010-06-25