FDA 510(k) Applications for Medical Device Product Code "KPT"
(Calibrator, Dose, Radionuclide)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K090296 | BIODEX MEDICAL SYSTEMS, INC. | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | 02/19/2009 |
| K101452 | CAPINTEC, INC. | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | 08/09/2010 |
| K071396 | CAPINTEC, INC. | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | 06/28/2007 |
| K192199 | Capintec, Inc. | CRC PC Smart Chamber K1 | 09/12/2019 |
| K141413 | CAPINTEC, INC. | CRC PC WITH SMART CHAMBER | 06/27/2014 |
| K020150 | CAPINTEC, INC. | CRC-15BT | 08/02/2002 |
| K162394 | Capintec, Inc. | CRC-77tHR | 03/08/2017 |
| K142325 | Comecer Netherlands b.v. | Veenstra Instruments VDC-506 Dose Calibrator | 09/18/2014 |
| K042746 | COMECER S.R.L. | PET-DOSE | 11/22/2004 |
| K011493 | MENTOR CORP. | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | 10/01/2002 |
| K010417 | NUCLEAR ASSOC., DIV. INOVISION LP | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | 04/26/2001 |
| K030066 | NUCLEAR ASSOCIATES | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | 08/29/2003 |
| K002833 | STANDARD IMAGING, INC. | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | 09/28/2000 |
| K013548 | STANDARD IMAGING, INC. | STANDARD IMAGING IVB 1000 WELL CHAMBER | 11/09/2001 |
| K013689 | SUN NUCLEAR CORP. | RE-ENTRANT CHAMBER | 07/02/2002 |
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