NemoScan

System, Image Processing, Radiological

Software Nemotec S.L.

The following data is part of a premarket notification filed by Software Nemotec S.l. with the FDA for Nemoscan.

Pre-market Notification Details

• Device ID: K192571
• 510k Number: K192571
• Device Name: NemoScan
• Classification: System, Image Processing, Radiological
• Applicant: Software Nemotec S.L. Juan De La Cierva Street, 66 Arroyomolinos, Madrid, ES 28939
• Contact: Carlos Arias
• Correspondent: Kevin Walls; Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-18
• Decision Date: 2019-12-11