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510(k) K030066

CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 by Nuclear Associates — Product Code KPT

K030066 is an FDA 510(k) premarket notification submitted by Nuclear Associates for the device "CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165". The FDA issued a decision of Substantially Equivalent on August 29, 2003. The device falls under product code KPT (Calibrator, Dose, Radionuclide), a Class II device regulated under 21 CFR 892.1360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2003
Date Received
January 7, 2003
Clearance Type
Traditional
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

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  • 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)
  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)
  • K020150 — CRC-15BT (August 2, 2002)

FDA data resources