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510(k) K192199

CRC PC Smart Chamber K1 by Capintec, Inc. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2019
Date Received
August 13, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

Other clearances by Capintec, Inc.

  • 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)
  • K052595 — CRC 15ULTRA (November 8, 2005)
  • 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 KPT

  • K162394 — CRC-77tHR (March 8, 2017)
  • K142325 — Veenstra Instruments VDC-506 Dose Calibrator (September 18, 2014)
  • 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)
  • K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 A (February 19, 2009)
  • K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (June 28, 2007)
  • K042746 — PET-DOSE (November 22, 2004)
  • K030066 — CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 (August 29, 2003)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K020150 — CRC-15BT (August 2, 2002)