FIRSTVIEW

System, Image Processing, Radiological

RIVERAIN MEDICAL GROUP,LLC

The following data is part of a premarket notification filed by Riverain Medical Group,llc with the FDA for Firstview.

Pre-market Notification Details

• Device ID: K071492
• 510k Number: K071492
• Device Name: FIRSTVIEW
• Classification: System, Image Processing, Radiological
• Applicant: RIVERAIN MEDICAL GROUP,LLC 3020 SOUTH TECH BLVD. Miamisburg, OH 45342 -4860
• Contact: Jennifer Steinke
• Correspondent: Jennifer Steinke; RIVERAIN MEDICAL GROUP,LLC 3020 SOUTH TECH BLVD. Miamisburg, OH 45342 -4860
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-30
• Decision Date: 2007-08-28
• Summary: summary