Portray

Unit, X-ray, Extraoral With Timer

Surround Medical Systems

The following data is part of a premarket notification filed by Surround Medical Systems with the FDA for Portray.

Pre-market Notification Details

• Device ID: K211014
• 510k Number: K211014
• Device Name: Portray
• Classification: Unit, X-ray, Extraoral With Timer
• Applicant: Surround Medical Systems 175 Southport Dr, Suite 900 Morrisville, NC 27560
• Contact: Elizabeth Sullivan
• Correspondent: Elizabeth Sullivan; Surround Medical Systems 175 Southport Dr, Suite 900 Morrisville, NC 27560
• Product Code: EHD
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-05
• Decision Date: 2021-07-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850034901114	K211014	000
00850034901107	K211014	000
00850034901091	K211014	000
00850034901008	K211014	000