Product code KPT
- Device name
- Calibrator, Dose, Radionuclide
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1360
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | 2019-09-12 |
| K162394 | CRC-77tHR | Capintec, Inc. | 2017-03-08 |
| K142325 | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | 2014-09-18 |
| K141413 | CRC PC WITH SMART CHAMBER | Capintec, Inc. | 2014-06-27 |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Capintec, Inc. | 2010-08-09 |
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Biodex Medical Systems, Inc. | 2009-02-19 |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | 2007-06-28 |
| K042746 | PET-DOSE | Comecer S.R.L. | 2004-11-22 |
| K030066 | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | Nuclear Associates | 2003-08-29 |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Mentor Corp. | 2002-10-01 |
| K020150 | CRC-15BT | Capintec, Inc. | 2002-08-02 |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | 2002-07-02 |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | Standard Imaging, Inc. | 2001-11-09 |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | 2001-04-26 |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Standard Imaging, Inc. | 2000-09-28 |
| K943072 | BETA C COUNTER | Capintec Instruments, Inc. | 1994-09-29 |
| K935539 | CAPINTEC CRC 35R | Capintec Instruments, Inc. | 1994-02-18 |
| K931657 | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. | Victoreen, Inc. | 1993-07-27 |
| K905796 | DOSE CALIBRATOR | Capintec Instruments, Inc. | 1991-03-18 |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Atomic Products Corp. | 1989-02-16 |
| K880272 | CAL/RAD UPGRADE MODEL 1030 | Sun Nuclear Corp. | 1988-02-29 |
| K850838 | CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW | Clinicomp, Inc. | 1985-09-26 |
| K850815 | RADIOISOTOPE CALIBRATOR MODEL 34-062 | Victoreen, Inc. | 1985-08-21 |
| K842540 | CLINICOMP R.C.I. | Clinicomp, Inc. | 1984-08-08 |
| K842570 | LUDLUM 88 DOSE CALIBRATOR | Ludlum Measurements, Inc. | 1984-08-07 |
| K841785 | RADCAL MODEL 4046 RADIONUCLIDE CALIBR | Radcal Corp. | 1984-07-16 |
| K841786 | RADCAL MODEL 4051 RADIONUCLIDE CALIBRA | Radcal Corp. | 1984-07-16 |
| K841787 | RADCAL MODEL 4050 RADIONUCLIDE CALIB | Radcal Corp. | 1984-07-16 |
| K813379 | RADIONUCLIDE DOSE CALIBRATOR | Medi Nuclear Corp., Inc. | 1982-01-22 |
| K813065 | B.D.A.S. | General Electric Co. | 1981-12-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00718175003343 | Atomlab Wipe Test Counter | BIODEX MEDICAL SYSTEMS, INC. | 2020-02-14 |
| 08719324589017 | VIK203 | Comecer Netherlands B.V. | 2018-02-06 |
| 08719324589024 | IBC-Lite | Comecer Netherlands B.V. | 2018-02-06 |
| 08719324589048 | VDC606 | Comecer Netherlands B.V. | 2018-02-06 |
| 08719324589000 | VIK202 | Comecer Netherlands B.V. | 2018-02-05 |
| 00859942006065 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2017-06-20 |
| 00718175003350 | Atomlab Dose Calibrator | BIODEX MEDICAL SYSTEMS, INC. | 2016-11-02 |
| 00718175003329 | Atomlab 500 Plus | BIODEX MEDICAL SYSTEMS, INC. | 2016-11-02 |
| 00718175003305 | Atomlab 500 Dose Calibrator | BIODEX MEDICAL SYSTEMS, INC. | 2016-11-02 |
| 00866562000212 | Standard Imaging HDR 1000 Plus | STANDARD IMAGING INC. | 2016-10-11 |
| 00866562000250 | Standard Imaging IVB 1000 Well Chamber | STANDARD IMAGING INC. | 2016-10-11 |
| 00859942006072 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-27 |
| 00859942006089 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-27 |
| 00859942006003 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00859942006010 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00859942006058 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00859942006041 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00859942006034 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00859942006027 | Capintec Dose Calibrator | Mirion Technologies (capintec), Inc. | 2016-09-14 |
| 00813787020280 | I-Seed Agx100 | THERAGENICS CORPORATION | 2015-09-21 |
| 00813787020297 | I-Seed Agx100 | THERAGENICS CORPORATION | 2015-09-21 |
| 00813787020754 | TheraSeed | THERAGENICS CORPORATION | 2015-09-21 |
| 00813787020761 | TheraSeed | THERAGENICS CORPORATION | 2015-09-21 |