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510(k) K092105

RADIANALYZER XPRESS by Radi Medical Systems AB — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
July 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Radi Medical Systems AB

  • K123984 — QUANTIEN MEASUREMENT SYSTEM (March 28, 2013)
  • K080813 — PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (July 1, 2008)
  • K080206 — MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (February 26, 2008)
  • K062769 — PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (December 4, 2006)
  • K042628 — MODIFICATION TO: RADIANALYZER, MODEL 12711 (January 19, 2005)
  • K033291 — TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (March 17, 2004)
  • K031662 — PRESSURE WIRE SENSOR, MODELS 12004/12304 (June 6, 2003)
  • K024107 — FEMOSTOP FEMORAL COMPRESSION SYSTEM (December 24, 2002)
  • K022188 — RADIANALYZER, MODEL 12710 (October 3, 2002)
  • K022187 — PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 (September 24, 2002)

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