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510(k) K894568

NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM by Advanced Medical Systems, Inc. — Product Code KPQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1990
Date Received
July 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Simulation, Radiation Therapy
Device Class
Class II
Regulation Number
892.5840
Review Panel
RA
Submission Type

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  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

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