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510(k) K780157

RADIATION TREATMENT PLANNING SYSTEM by Capintec, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1978
Date Received
January 30, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

Other clearances by Capintec, Inc.

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  • K141413 — CRC PC WITH SMART CHAMBER (June 27, 2014)
  • K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55 (August 9, 2010)
  • K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (June 28, 2007)
  • K052595 — CRC 15ULTRA (November 8, 2005)
  • K030175 — 2 BASIC (April 17, 2003)
  • K020150 — CRC-15BT (August 2, 2002)
  • K982448 — CARDIOLIGHT (June 11, 1999)
  • K980402 — CAPINTEC MODEL 292 ELECTROMETER (April 24, 1998)

Other clearances for product code JAD

  • K250692 — GentleBeam (GB1000) (December 3, 2025)
  • K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric (January 10, 2025)
  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)
  • K213942 — Esteya (January 11, 2022)
  • K190255 — Sensus Healthcare TVM Balloon Applicator (February 21, 2019)
  • K182641 — Sensus IORT System (February 21, 2019)
  • K173425 — SRT-100+ (March 23, 2018)
  • K172080 — Photoelectric Therapy System (September 29, 2017)
  • K162568 — INTRABEAM 600 (December 15, 2016)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)