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510(k) K841786

Device
RADCAL MODEL 4051 RADIONUCLIDE CALIBRA
Applicant
RADCAL CORP.
510(k) number
K841786
Product code
KPT  
Decision
Substantially Equivalent (SESE)
Decision date
1984-07-16
Date received
1984-04-30
Regulation
892.1360
Classification name
Calibrator, Dose, Radionuclide
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192199CRC PC Smart Chamber K1Capintec, Inc.2019-09-12
K162394CRC-77tHRCapintec, Inc.2017-03-08
K142325Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V.2014-09-18
K141413CRC PC WITH SMART CHAMBERCapintec, Inc.2014-06-27
K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.2010-08-09
K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.2009-02-19
K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.2007-06-28
K042746PET-DOSEComecer S.R.L.2004-11-22
K030066CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165Nuclear Associates2003-08-29
K011493MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPYMentor Corp.2002-10-01
K020150CRC-15BTCapintec, Inc.2002-08-02
K013689RE-ENTRANT CHAMBERSun Nuclear Corp.2002-07-02
K013548STANDARD IMAGING IVB 1000 WELL CHAMBERStandard Imaging, Inc.2001-11-09
K010417CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304Nuclear Assoc., Div. Inovision LP2001-04-26
K002833MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBERStandard Imaging, Inc.2000-09-28

Legacy Summary#

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FDA Review#

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