Calibrator, Dose, Radionuclide
Regulation 892.1360
0510(k)s in 12 months (32 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in KPT
| Company | 510(k)s | Recalls |
|---|---|---|
| Capintec, Inc. | 6 | 2 |
| Biodex Medical Systems, Inc. | 1 | 2 |
| Capintec Instruments, Inc. | 3 | 0 |
| Radcal Corp. | 3 | 0 |
| Clinicomp, Inc. | 2 | 0 |
| Standard Imaging, Inc. | 2 | 0 |
| Sun Nuclear Corp. | 2 | 0 |
| Victoreen, Inc. | 2 | 0 |
| Atomic Products Corp. | 1 | 0 |
| Comecer Netherlands B.V. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2019 | K192199 | CRC PC Smart Chamber K1 Capintec, Inc. | KPT |
| Mar 8, 2017 | K162394 | CRC-77tHR Capintec, Inc. | KPT |
| Sep 18, 2014 | K142325 | Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands B.V., NL | KPT |
| Jun 27, 2014 | K141413 | CRC PC WITH SMART CHAMBER Capintec, Inc. | KPT |
| Aug 9, 2010 | K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW Capintec, Inc. | KPT |
| Feb 19, 2009 | K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 Biodex Medical Systems, Inc. | KPT |
| Jun 28, 2007 | K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS Capintec, Inc. | KPT |
| Nov 22, 2004 | K042746 | PET-DOSE Comecer S.R.L. | KPT |
| Aug 29, 2003 | K030066 | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 Nuclear Associates | KPT |
| Oct 1, 2002 | K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY Mentor Corp. | KPT |
| Aug 2, 2002 | K020150 | CRC-15BT Capintec, Inc. | KPT |
| Jul 2, 2002 | K013689 | RE-ENTRANT CHAMBER Sun Nuclear Corp. | KPT |
| Nov 9, 2001 | K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER Standard Imaging, Inc. | KPT |
| Apr 26, 2001 | K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 Nuclear Assoc., Div. Inovision LP | KPT |
| Sep 28, 2000 | K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER Standard Imaging, Inc. | KPT |
| Sep 29, 1994 | K943072 | BETA C COUNTER Capintec Instruments, Inc. | KPT |
| Feb 18, 1994 | K935539 | CAPINTEC CRC 35R Capintec Instruments, Inc. | KPT |
| Jul 27, 1993 | K931657 | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. Victoreen, Inc. | KPT |
| Mar 18, 1991 | K905796 | DOSE CALIBRATOR Capintec Instruments, Inc. | KPT |
| Feb 16, 1989 | K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 Atomic Products Corp. | KPT |
| Feb 29, 1988 | K880272 | CAL/RAD UPGRADE MODEL 1030 Sun Nuclear Corp. | KPT |
| Sep 26, 1985 | K850838 | CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW Clinicomp, Inc. | KPT |
| Aug 21, 1985 | K850815 | RADIOISOTOPE CALIBRATOR MODEL 34-062 Victoreen, Inc. | KPT |
| Aug 8, 1984 | K842540 | CLINICOMP R.C.I. Clinicomp, Inc. | KPT |
| Aug 7, 1984 | K842570 | LUDLUM 88 DOSE CALIBRATOR Ludlum Measurements, Inc. | KPT |
| Jul 16, 1984 | K841787 | RADCAL MODEL 4050 RADIONUCLIDE CALIB Radcal Corp. | KPT |
| Jul 16, 1984 | K841786 | RADCAL MODEL 4051 RADIONUCLIDE CALIBRA Radcal Corp. | KPT |
| Jul 16, 1984 | K841785 | RADCAL MODEL 4046 RADIONUCLIDE CALIBR Radcal Corp. | KPT |
| Jan 22, 1982 | K813379 | RADIONUCLIDE DOSE CALIBRATOR Medi Nuclear Corp., Inc. | KPT |
| Dec 8, 1981 | K813065 | B.D.A.S. General Electric Co. | KPT |
| Jun 2, 1981 | K811320 | CAL-3 CALIBRATED RADIOACTIVITY ASSAYER Dosimeter Corp. | KPT |
| Apr 5, 1977 | K770515 | DISPENSER, TECHNETIUM, CLINTICHEM Union Carbide Corp. | KPT |
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