LEONARDO

System, Image Processing, Radiological

SIEMENS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Leonardo.

Pre-market Notification Details

• Device ID: K040970
• 510k Number: K040970
• Device Name: LEONARDO
• Classification: System, Image Processing, Radiological
• Applicant: SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Contact: Ana Ladino
• Correspondent: Ana Ladino; SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 -1406
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-04-14
• Decision Date: 2004-07-08
• Summary: summary