Home / 510(k) Clearances / K050692

510(k) K050692

FLXIS by Philips Medical Systems North America Co. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2005
Date Received
March 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Philips Medical Systems North America Co.

  • K101311 — EP NAVIGATOR R3 (September 30, 2010)
  • K102005 — ALLURA XPER OR TABLE SERIES (August 9, 2010)
  • K090625 — WIRELESS PORTABLE DETECTOR FD-W17 (March 24, 2009)
  • 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)

Other clearances for product code JAA

  • K251650 — Insight Enhanced™ DRF (EN-1002-01) (September 16, 2025)
  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)