SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

System, Planning, Radiation Therapy Treatment

ECKERT & ZIEGLER BEBIG GMBH

The following data is part of a premarket notification filed by Eckert & Ziegler Bebig Gmbh with the FDA for Sagiplan, Sagiplan Prostate Module Add On, Sagiplan Including Prostate Module.

Pre-market Notification Details

• Device ID: K141900
• 510k Number: K141900
• Device Name: SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE
• Classification: System, Planning, Radiation Therapy Treatment
• Applicant: ECKERT & ZIEGLER BEBIG GMBH MUURZWALUW 30 Veenendaal, NL 3905rz
• Contact: Hub Van De Bergh
• Correspondent: Hub Van De Bergh; ECKERT & ZIEGLER BEBIG GMBH MUURZWALUW 30 Veenendaal, NL 3905rz
• Product Code: MUJ
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-14
• Decision Date: 2015-05-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04049223118211	K141900	000
04049223106751	K141900	000
04049223132088	K141900	000
04065983000047	K141900	000
04065983000016	K141900	000