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510(k) K051055

INTRABEAM SYSTEM by Carl Zeiss Surgical GmbH — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2005
Date Received
April 26, 2005
Clearance Type
Special
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

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  • K090584 — INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS (November 24, 2009)

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  • 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)