Home / 510(k) Clearances / K130549

510(k) K130549

INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR by Carl Zeiss Meditec, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2013
Date Received
March 4, 2013
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 Meditec, Inc.

  • K243878 — CLARUS (700) (April 17, 2025)
  • K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric (January 10, 2025)
  • K233911 — VISULAS combi (September 6, 2024)
  • K240215 — BLUE 400; BLUE 400 S (June 28, 2024)
  • K233933 — CIRRUS™ HD-OCT Model 6000 (May 17, 2024)
  • K233421 — RESCAN 700 (March 8, 2024)
  • K232944 — CALLISTO eye (December 21, 2023)
  • K232051 — VISULAS green (October 24, 2023)
  • K230350 — VISULAS yag (September 22, 2023)
  • K232159 — QEVO System (September 21, 2023)

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)