ONDEMAND3D

System, Image Processing, Radiological

CYBERMED, INC.

The following data is part of a premarket notification filed by Cybermed, Inc. with the FDA for Ondemand3d.

Pre-market Notification Details

• Device ID: K113543
• 510k Number: K113543
• Device Name: ONDEMAND3D
• Classification: System, Image Processing, Radiological
• Applicant: CYBERMED, INC. #504 SJ TECHNOVILLE, GASAN-DONG 60-19, GEUMCHEON-GU Seoul, KR 153-710
• Contact: Yong Ki Im
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2011-12-01
• Decision Date: 2011-12-16
• Summary: summary