ENCOMPASS

System, X-ray, Extraoral Source, Digital

PANORAMIC CORP.

The following data is part of a premarket notification filed by Panoramic Corp. with the FDA for Encompass.

Pre-market Notification Details

• Device ID: K141130
• 510k Number: K141130
• Device Name: ENCOMPASS
• Classification: System, X-ray, Extraoral Source, Digital
• Applicant: PANORAMIC CORP. 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm, P.e.
• Correspondent: Daniel Kamm, P.e.; PANORAMIC CORP. 8870 RAVELLO CT Naples, FL 34114
• Product Code: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-05-01
• Decision Date: 2014-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00862309000361	K141130	000