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510(k) K010417

CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 by Nuclear Assoc., Div. Inovision LP — Product Code KPT

K010417 is an FDA 510(k) premarket notification submitted by Nuclear Assoc., Div. Inovision LP for the device "CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304". The FDA issued a decision of Substantially Equivalent on April 26, 2001. 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
April 26, 2001
Date Received
February 12, 2001
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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  • K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (June 28, 2007)
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  • K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA (October 1, 2002)

FDA data resources