DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)

System, X-ray, Tomographic

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Xr656 With Volumerad (digital Tomosynthesis).

Pre-market Notification Details

• Device ID: K132261
• 510k Number: K132261
• Device Name: DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
• Classification: System, X-ray, Tomographic
• Applicant: GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188
• Contact: John L Schmidt
• Correspondent: John L Schmidt; GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188
• Product Code: IZF
• CFR Regulation Number: 892.1740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-19
• Decision Date: 2013-11-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682146210	K132261	000
00840682115322	K132261	000