LUNAR IDXA

Densitometer, Bone

GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA

The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Dia with the FDA for Lunar Idxa.

Pre-market Notification Details

• Device ID: K052581
• 510k Number: K052581
• Device Name: LUNAR IDXA
• Classification: Densitometer, Bone
• Applicant: GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 726 HEARTLAND TRAIL Madison, WI 53717
• Contact: James P Raskob
• Correspondent: James P Raskob; GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA 726 HEARTLAND TRAIL Madison, WI 53717
• Product Code: KGI
• CFR Regulation Number: 892.1170 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-09-20
• Decision Date: 2005-10-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682117029	K052581	000