Product code KPT— Radiology

FDA has cleared 32 devices under product code KPT between 1977 and 2019, filed by 19 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20191 clearance
• 20171 clearance
• 20142 clearances
• 20101 clearance
• 20091 clearance
• 20071 clearance
• 20041 clearance
• 20031 clearance
• 20023 clearances
• 20012 clearances
• 20001 clearance
• 19942 clearances
• 19931 clearance
• 19911 clearance
• 19891 clearance

• Capintec, Inc.6 clearances
• Radcal Corp.3 clearances
• Capintec Instruments, Inc.3 clearances
• Victoreen, Inc.2 clearances
• Sun Nuclear Corp.2 clearances
• Standard Imaging, Inc.2 clearances
• Clinicomp, Inc.2 clearances
• Union Carbide Corp.1 clearance
• Nuclear Associates1 clearance
• Nuclear Assoc., Div. Inovision LP1 clearance

• K192199 — CRC PC Smart Chamber K1Capintec, Inc.·2019-09-12
• K162394 — CRC-77tHRCapintec, Inc.·2017-03-08
• K142325 — Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V.·2014-09-18
• K141413 — CRC PC WITH SMART CHAMBERCapintec, Inc.·2014-06-27
• K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.·2010-08-09
• K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.·2009-02-19
• K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.·2007-06-28
• K042746 — PET-DOSEComecer S.R.L.·2004-11-22
• K030066 — CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165Nuclear Associates·2003-08-29
• K011493 — MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPYMentor Corp.·2002-10-01
• K020150 — CRC-15BTCapintec, Inc.·2002-08-02
• K013689 — RE-ENTRANT CHAMBERSun Nuclear Corp.·2002-07-02
• K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBERStandard Imaging, Inc.·2001-11-09
• K010417 — CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304Nuclear Assoc., Div. Inovision LP·2001-04-26
• K002833 — MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBERStandard Imaging, Inc.·2000-09-28
• K943072 — BETA C COUNTERCapintec Instruments, Inc.·1994-09-29
• K935539 — CAPINTEC CRC 35RCapintec Instruments, Inc.·1994-02-18
• K931657 — NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.Victoreen, Inc.·1993-07-27
• K905796 — DOSE CALIBRATORCapintec Instruments, Inc.·1991-03-18
• K884312 — ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270Atomic Products Corp.·1989-02-16
• K880272 — CAL/RAD UPGRADE MODEL 1030Sun Nuclear Corp.·1988-02-29
• K850838 — CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTWClinicomp, Inc.·1985-09-26
• K850815 — RADIOISOTOPE CALIBRATOR MODEL 34-062Victoreen, Inc.·1985-08-21
• K842540 — CLINICOMP R.C.I.Clinicomp, Inc.·1984-08-08
• K842570 — LUDLUM 88 DOSE CALIBRATORLudlum Measurements, Inc.·1984-08-07
• K841785 — RADCAL MODEL 4046 RADIONUCLIDE CALIBRRadcal Corp.·1984-07-16
• K841786 — RADCAL MODEL 4051 RADIONUCLIDE CALIBRARadcal Corp.·1984-07-16
• K841787 — RADCAL MODEL 4050 RADIONUCLIDE CALIBRadcal Corp.·1984-07-16
• K813379 — RADIONUCLIDE DOSE CALIBRATORMedi Nuclear Corp., Inc.·1982-01-22
• K813065 — B.D.A.S.General Electric Co.·1981-12-08
• K811320 — CAL-3 CALIBRATED RADIOACTIVITY ASSAYERDosimeter Corp.·1981-06-02
• K770515 — DISPENSER, TECHNETIUM, CLINTICHEMUnion Carbide Corp.·1977-04-05