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510(k) K090584

INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS by Carl Zeiss Surgical GmbH — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2009
Date Received
March 3, 2009
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 Carl Zeiss Surgical GmbH

  • K110590 — INTRABEAM NEEDLE APPLICATOR (April 13, 2012)
  • K100468 — ZEISS INFRARED 800 WITH FLOW 800 OPTION (March 3, 2010)
  • K051055 — INTRABEAM SYSTEM (May 23, 2005)

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  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)
  • K213942 — Esteya (January 11, 2022)
  • K182641 — Sensus IORT System (February 21, 2019)
  • K190255 — Sensus Healthcare TVM Balloon Applicator (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)