StarGuide

System, Tomography, Computed, Emission

GE Healthcare

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Starguide.

Pre-market Notification Details

• Device ID: K210173
• 510k Number: K210173
• Device Name: StarGuide
• Classification: System, Tomography, Computed, Emission
• Applicant: GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200
• Contact: George Mashour
• Correspondent: George Mashour; GE Healthcare 4 Hayozma Street Tirat Hacarmel, IL 30200
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-22
• Decision Date: 2021-03-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195278118295	K210173	000
00195278755544	K210173	000
00195278870490	K210173	000