GEMINI RAPTOR

System, Tomography, Computed, Emission

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Gemini Raptor.

Pre-market Notification Details

• Device ID: K052640
• 510k Number: K052640
• Device Name: GEMINI RAPTOR
• Classification: System, Tomography, Computed, Emission
• Applicant: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143
• Contact: Melinda Novatny
• Product Code: KPS
• CFR Regulation Number: 892.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2005-09-26
• Decision Date: 2005-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838059443	K052640	000