GC70

System, X-ray, Stationary

Samsung Electronics Co., Ltd.

The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gc70.

Pre-market Notification Details

• Device ID: K182647
• 510k Number: K182647
• Device Name: GC70
• Classification: System, X-ray, Stationary
• Applicant: Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu, Suwon-si, KR 16677
• Contact: Jaesang Noh
• Correspondent: Jaesang Noh; Samsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu, Suwon-si, KR 16677
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-24
• Decision Date: 2018-10-24
• Summary: summary