Aria

Densitometer, Bone

GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics,llc with the FDA for Aria.

Pre-market Notification Details

• Device ID: K180782
• 510k Number: K180782
• Device Name: Aria
• Classification: Densitometer, Bone
• Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC 3030 Ohmeda Drive Madison, WI 53718
• Contact: Nicole Landreville
• Correspondent: Nicole Landreville; GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC 3030 Ohmeda Drive Madison, WI 53718
• Product Code: KGI
• CFR Regulation Number: 892.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-26
• Decision Date: 2018-04-20
• Summary: summary