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510(k) K993400

HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES by Mick Radio-Nuclear Instruments, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2000
Date Received
October 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type

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  • K142597 — Vienna System (February 19, 2015)
  • K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (December 14, 2012)
  • K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR (December 26, 2006)
  • K063381 — CT COMPATIBLE F/S/D APPLICATORS (December 22, 2006)
  • K052351 — HDR IORT SHIELDED APPLICATOR (October 17, 2005)
  • K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (July 1, 2005)
  • K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLI (June 18, 2004)

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  • K250289 — Intracavitary/Interstitial System (April 25, 2025)
  • K243939 — Titanium Flexible Geometry FSD Applicator Set (GM11013400) (March 3, 2025)
  • K241764 — Mould Probe MR Safe (January 10, 2025)
  • K242961 — Intraluminal Applicator Set (November 26, 2024)
  • K243045 — “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (November 19, 2024)
  • K241853 — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (November 7, 2024)
  • K241965 — Catheter Surface Flap Applicator Set (GM11011830) (October 29, 2024)