KPT — Calibrator, Dose, Radionuclide Class II
FDA Device Classification
Classification Details
- Product Code
- KPT
- Device Class
- Class II
- Regulation Number
- 892.1360
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K192199 | capintec | CRC PC Smart Chamber K1 | September 12, 2019 |
| K162394 | capintec | CRC-77tHR | March 8, 2017 |
| K142325 | comecer netherlands | Veenstra Instruments VDC-506 Dose Calibrator | September 18, 2014 |
| K141413 | capintec | CRC PC WITH SMART CHAMBER | June 27, 2014 |
| K101452 | capintec | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55 | August 9, 2010 |
| K090296 | biodex medical systems | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 A | February 19, 2009 |
| K071396 | capintec | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | June 28, 2007 |
| K042746 | comecer | PET-DOSE | November 22, 2004 |
| K030066 | nuclear associates | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | August 29, 2003 |
| K011493 | mentor | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRA | October 1, 2002 |
| K020150 | capintec | CRC-15BT | August 2, 2002 |
| K013689 | sun nuclear | RE-ENTRANT CHAMBER | July 2, 2002 |
| K013548 | standard imaging | STANDARD IMAGING IVB 1000 WELL CHAMBER | November 9, 2001 |
| K010417 | nuclear assoc., div. inovision | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | April 26, 2001 |
| K002833 | standard imaging | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | September 28, 2000 |
| K943072 | capintec instruments | BETA C COUNTER | September 29, 1994 |
| K935539 | capintec instruments | CAPINTEC CRC 35R | February 18, 1994 |
| K931657 | victoreen | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. | July 27, 1993 |
| K905796 | capintec instruments | DOSE CALIBRATOR | March 18, 1991 |
| K884312 | atomic products | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | February 16, 1989 |