KPT · Class II · 21 CFR 892.1360

FDA Product Code KPT: Calibrator, Dose, Radionuclide

Leading manufacturers include Capintec, Inc., Radcal Corp. and Capintec Instruments, Inc..

32
Total
32
Cleared
97d
Avg days
1977
Since

FDA 510(k) Cleared Calibrator, Dose, Radionuclide Devices (Product Code KPT)

32 devices
1–24 of 32
Cleared Sep 12, 2019
CRC PC Smart Chamber K1
K192199
Capintec, Inc.
Radiology · 30d
Cleared Mar 08, 2017
CRC-77tHR
K162394
Capintec, Inc.
Radiology · 194d
Cleared Sep 18, 2014
Veenstra Instruments VDC-506 Dose Calibrator
K142325
Comecer Netherlands B.V.
Radiology · 29d
Cleared Jun 27, 2014
CRC PC WITH SMART CHAMBER
K141413
Capintec, Inc.
Radiology · 29d
Cleared Aug 09, 2010
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
K101452
Capintec, Inc.
Radiology · 76d
Cleared Feb 19, 2009
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
K090296
Biodex Medical Systems, Inc.
Radiology · 13d
Cleared Jun 28, 2007
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
K071396
Capintec, Inc.
Radiology · 38d
Cleared Nov 22, 2004
PET-DOSE
K042746
Comecer S.R.L.
Radiology · 49d
Cleared Aug 29, 2003
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
K030066
Nuclear Associates
Radiology · 234d
Cleared Oct 01, 2002
MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
K011493
Mentor Corp.
Radiology · 504d
Cleared Aug 02, 2002
CRC-15BT
K020150
Capintec, Inc.
Radiology · 198d
Cleared Jul 02, 2002
RE-ENTRANT CHAMBER
K013689
Sun Nuclear Corp.
Radiology · 238d
Cleared Nov 09, 2001
STANDARD IMAGING IVB 1000 WELL CHAMBER
K013548
Standard Imaging, Inc.
Radiology · 16d
Cleared Apr 26, 2001
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417
Nuclear Assoc., Div. Inovision LP
Radiology · 73d
Cleared Sep 28, 2000
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
K002833
Standard Imaging, Inc.
Radiology · 16d
Cleared Sep 29, 1994
BETA C COUNTER
K943072
Capintec Instruments, Inc.
Radiology · 93d
Cleared Feb 18, 1994
CAPINTEC CRC 35R
K935539
Capintec Instruments, Inc.
Radiology · 94d
Cleared Jul 27, 1993
NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.
K931657
Victoreen, Inc.
Radiology · 113d
Cleared Mar 18, 1991
DOSE CALIBRATOR
K905796
Capintec Instruments, Inc.
Radiology · 81d
Cleared Feb 16, 1989
ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
K884312
Atomic Products Corp.
Radiology · 126d
Cleared Feb 29, 1988
CAL/RAD UPGRADE MODEL 1030
K880272
Sun Nuclear Corp.
Radiology · 39d
Cleared Sep 26, 1985
CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW
K850838
Clinicomp, Inc.
Radiology · 209d
Cleared Aug 21, 1985
RADIOISOTOPE CALIBRATOR MODEL 34-062
K850815
Victoreen, Inc.
Radiology · 174d
Cleared Aug 08, 1984
CLINICOMP R.C.I.
K842540
Clinicomp, Inc.
Radiology · 37d

About Product Code KPT - Regulatory Context