Calibrator, Dose, Radionuclide
FDA product code KPT · Class II (moderate risk) · 21 CFR 892.1360 · Radiology
32510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Capintec, Inc. 6
- Radcal Corp. 3
- Capintec Instruments, Inc. 3
- Clinicomp, Inc. 2
- Victoreen, Inc. 2
- Sun Nuclear Corp. 2
- Standard Imaging, Inc. 2
- Atomic Products Corp. 1
- Comecer Netherlands B.V. 1
- Biodex Medical Systems, Inc. 1
- Comecer S.R.L. 1
- Nuclear Associates 1
- Mentor Corp. 1
- Nuclear Assoc., Div. Inovision LP 1
- Union Carbide Corp. 1
- Ludlum Measurements, Inc. 1
- Medi Nuclear Corp., Inc. 1
- General Electric Co. 1
- Dosimeter Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1KPT · Special | Capintec, Inc. | 09/12/2019SE |
| K162394 | CRC-77tHRKPT · Traditional | Capintec, Inc. | 03/08/2017SE |
| K142325 | Veenstra Instruments VDC-506 Dose CalibratorKPT · Special | Comecer Netherlands B.V. | 09/18/2014SE |
| K141413 | CRC PC with Smart ChamberKPT · Special | Capintec, Inc. | 06/27/2014SE |
| K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special | Capintec, Inc. | 08/09/2010SE |
| K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336KPT · Traditional | Biodex Medical Systems, Inc. | 02/19/2009SE |
| K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special | Capintec, Inc. | 06/28/2007SE |
| K042746 | Pet-DoseKPT · Traditional | Comecer S.R.L. | 11/22/2004SE |
| K030066 | Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165KPT · Traditional | Nuclear Associates | 08/29/2003SE |
| K011493 | Mentor Isoloader Automatic Needle Loading System and Physics Workstation for BrachytherapyKPT · Traditional | Mentor Corp. | 10/01/2002SE |
| K020150 | CRC-15BTKPT · Traditional | Capintec, Inc. | 08/02/2002SE |
| K013689 | Re-Entrant ChamberKPT · Traditional | Sun Nuclear Corp. | 07/02/2002SE |
| K013548 | Standard Imaging Ivb 1000 Well ChamberKPT · Special | Standard Imaging, Inc. | 11/09/2001SE |
| K010417 | Cal/Rad Mark Iv-Dose Calibrator 34-162 Veenstra Model # VDC-304KPT · Traditional | Nuclear Assoc., Div. Inovision LP | 04/26/2001SE |
| K002833 | Modification to Standard Imaging PT 1000 Ion ChamberKPT · Special | Standard Imaging, Inc. | 09/28/2000SE |
| K943072 | Beta C CounterKPT · Traditional | Capintec Instruments, Inc. | 09/29/1994SE |
| K935539 | Capintec CRC 35RKPT · Traditional | Capintec Instruments, Inc. | 02/18/1994SE |
| K931657 | Nuclear Associates Model 34-070 Brachytherapy Cal.KPT · Traditional | Victoreen, Inc. | 07/27/1993SE |
| K905796 | Dose CalibratorKPT · Traditional | Capintec Instruments, Inc. | 03/18/1991SE |
| K884312 | Atomlab 100, Model 086-250 & 200 Model 086-270KPT · Traditional | Atomic Products Corp. | 02/16/1989SE |
| K880272 | Cal/Rad Upgrade Model 1030KPT · Traditional | Sun Nuclear Corp. | 02/29/1988SE |
| K850838 | Clinicomp RDMS Radionuclide Dispensing Mgmt. SoftwKPT · Traditional | Clinicomp, Inc. | 09/26/1985SE |
| K850815 | Radioisotope Calibrator Model 34-062KPT · Traditional | Victoreen, Inc. | 08/21/1985SE |
| K842540 | Clinicomp R.C.I.KPT · Traditional | Clinicomp, Inc. | 08/08/1984SE |
| K842570 | Ludlum 88 Dose CalibratorKPT · Traditional | Ludlum Measurements, Inc. | 08/07/1984SE |
| K841787 | Radcal Model 4050 Radionuclide CalibKPT · Traditional | Radcal Corp. | 07/16/1984SE |
| K841786 | Radcal Model 4051 Radionuclide CalibraKPT · Traditional | Radcal Corp. | 07/16/1984SE |
| K841785 | Radcal Model 4046 Radionuclide CalibrKPT · Traditional | Radcal Corp. | 07/16/1984SE |
| K813379 | Radionuclide Dose CalibratorKPT · Traditional | Medi Nuclear Corp., Inc. | 01/22/1982SE |
| K813065 | B.D.A.S.KPT · Traditional | General Electric Co. | 12/08/1981SE |
| K811320 | CAL-3 Calibrated Radioactivity AssayerKPT · Traditional | Dosimeter Corp. | 06/02/1981SE |
| K770515 | Dispenser, Technetium, ClintichemKPT · Traditional | Union Carbide Corp. | 04/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2581-2021 Class II | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model:…When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated… | Biodex Medical Systems, Inc. | 08/16/2021Terminated |
| Z-2580-2021 Class II | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model:…When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated… | Biodex Medical Systems, Inc. | 08/16/2021Terminated |
| Z-0177-2012 | Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET…Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET | Capintec Inc | 07/08/2011Terminated |
| Z-0167-2011 | Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number…The spring arm on portable stand may have been over tightened during assembly, which may result in failure.… | Capintec Inc | 09/20/2010Terminated |