DYNACT

System, X-ray, Angiographic

SIEMENS MEDICAL SYSTEMS, INC.

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

Pre-market Notification Details

• Device ID: K042646
• 510k Number: K042646
• Device Name: DYNACT
• Classification: System, X-ray, Angiographic
• 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: IZI
• CFR Regulation Number: 892.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-28
• Decision Date: 2004-10-19
• Summary: summary