ZIOSTATION

System, Image Processing, Radiological

ZIOSOFT, INC.

The following data is part of a premarket notification filed by Ziosoft, Inc. with the FDA for Ziostation.

Pre-market Notification Details

• Device ID: K070205
• 510k Number: K070205
• Device Name: ZIOSTATION
• Classification: System, Image Processing, Radiological
• Applicant: ZIOSOFT, INC. 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604
• Contact: Marc Goodman
• Correspondent: Marc Goodman; ZIOSOFT, INC. 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-22
• Decision Date: 2007-03-23
• Summary: summary