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510(k) K991237

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL by Radionics, Inc. — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1999
Date Received
April 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Radionics, Inc.

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  • K992226 — XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (August 4, 2000)
  • K001950 — OPTICAL TRACKING SYSTEM (OTS) (July 26, 2000)
  • K001700 — XPLAN 2.1 (June 28, 2000)
  • K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (May 17, 2000)
  • K000057 — RADIONICS LUMBOPERITONEAL SHUNT (March 20, 2000)
  • K993594 — CONFORMAX MMLC VR1 (December 15, 1999)
  • K991399 — RADIONICS MICROELECTRODE KIT (September 21, 1999)

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