XCELERA

System, Image Processing, Radiological

PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.

The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Xcelera.

Pre-market Notification Details

• Device ID: K061995
• 510k Number: K061995
• Device Name: XCELERA
• Classification: System, Image Processing, Radiological
• Applicant: PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003
• Contact: Lynn T Harmer
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-07-14
• Decision Date: 2006-09-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838076730	K061995	000
00884838070646	K061995	000