SURGICASE

System, Image Processing, Radiological

MATERIALISE N.V.

The following data is part of a premarket notification filed by Materialise N.v. with the FDA for Surgicase.

Pre-market Notification Details

• Device ID: K073449
• 510k Number: K073449
• Device Name: SURGICASE
• Classification: System, Image Processing, Radiological
• Applicant: MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
• Contact: Mieke Janssen
• Correspondent: Mieke Janssen; MATERIALISE N.V. 15 TECHNOLOGIELAAN Leuven, BE 3001
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-12-10
• Decision Date: 2008-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E314SURGICASECMF0	K073449	000
E314PROPLANCMFCONNECT0	K073449	000