C-QUEST

System, Tomography, Computed, Emission

MEDX, INC.

The following data is part of a premarket notification filed by Medx, Inc. with the FDA for C-quest.

Pre-market Notification Details

• Device ID: K082581
• 510k Number: K082581
• Device Name: C-QUEST
• Classification: System, Tomography, Computed, Emission
• Applicant: MEDX, INC. 220 RIVER ROAD Claremont, NH 03743
• Contact: William Greenrose
• Correspondent: William Greenrose; MEDX, INC. 220 RIVER ROAD Claremont, NH 03743
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-05
• Decision Date: 2008-11-14
• Summary: summary