Home / 510(k) Clearances / K052595

510(k) K052595

CRC 15ULTRA by Capintec, Inc. — Product Code JAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2005
Date Received
September 21, 2005
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

Other clearances by Capintec, Inc.

  • K192199 — CRC PC Smart Chamber K1 (September 12, 2019)
  • K162394 — CRC-77tHR (March 8, 2017)
  • 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)
  • 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)
  • K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (March 30, 1995)

Other clearances for product code JAQ

  • K251037 — Rectal Applicator (December 19, 2025)
  • K252884 — Guided Aarhus Applicator Set (November 19, 2025)
  • K250299 — CT/ MR Tandem and Ovoid Set (May 9, 2025)
  • 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)