KPT — Calibrator, Dose, Radionuclide Class II
FDA product code KPT covers "Calibrator, Dose, Radionuclide", a Class II medical device regulated under 21 CFR 892.1360. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |