DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS

System, X-ray, Tomography, Computed

GE MEDICAL SYSTEMS, LLC

The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for Discovery Model Ct590 Rt And Optima Model Ct580 Ct Systems.

Pre-market Notification Details

• Device ID: K093581
• 510k Number: K093581
• Device Name: DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
• Classification: System, X-ray, Tomography, Computed
• Applicant: GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188
• Contact: Tracey Ortiz
• Correspondent: Tracey Ortiz; GE MEDICAL SYSTEMS, LLC 3000 N GRANDVIEW BLVD. Waukesha, WI 53188
• Product Code: JAK
• CFR Regulation Number: 892.1750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-11-18
• Decision Date: 2011-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682118699	K093581	000
00840682118552	K093581	000
00840682102513	K093581	000