VOXBOX

Illuminator, Radiographic-film

VOXEL

The following data is part of a premarket notification filed by Voxel with the FDA for Voxbox.

Pre-market Notification Details

• Device ID: K954199
• 510k Number: K954199
• Device Name: VOXBOX
• Classification: Illuminator, Radiographic-film
• Applicant: VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653
• Contact: Murray Rudin
• Correspondent: Murray Rudin; VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653
• Product Code: IXC
• CFR Regulation Number: 892.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-06
• Decision Date: 1995-09-29