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510(k) K102005

ALLURA XPER OR TABLE SERIES by Philips Medical Systems North America, Inc. — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2010
Date Received
July 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Philips Medical Systems North America, Inc.

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  • K090590 — VERADIUS, MODEL 718-130 (March 16, 2009)
  • K082280 — SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 (October 8, 2008)
  • K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE (January 5, 2007)
  • K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR (November 22, 2006)
  • K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A0 (October 18, 2006)
  • K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MO (September 20, 2006)
  • K061685 — PULSERA (September 15, 2006)
  • K061995 — XCELERA (September 6, 2006)

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