KPT · Calibrator, Dose, Radionuclide
Radiology · 21 CFR 892.1360 · Class 2
Overview
| Product Code | KPT |
|---|---|
| Device Name | Calibrator, Dose, Radionuclide |
| Regulation | 21 CFR 892.1360 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 32)
Showing 20 most recent of 32 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | Sep 12, 2019 | SESE |
| K162394 | CRC-77tHR | Capintec, Inc. | Mar 8, 2017 | SESE |
| K142325 | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | Sep 18, 2014 | SESE |
| K141413 | CRC PC WITH SMART CHAMBER | Capintec, Inc. | Jun 27, 2014 | SESE |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Capintec, Inc. | Aug 9, 2010 | SESE |
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Biodex Medical Systems, Inc. | Feb 19, 2009 | SESE |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | Jun 28, 2007 | SESE |
| K042746 | PET-DOSE | Comecer S.R.L. | Nov 22, 2004 | SESE |
| K030066 | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | Nuclear Associates | Aug 29, 2003 | SESE |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Mentor Corp. | Oct 1, 2002 | SESE |
| K020150 | CRC-15BT | Capintec, Inc. | Aug 2, 2002 | SESE |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | Jul 2, 2002 | SESE |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | Standard Imaging, Inc. | Nov 9, 2001 | SESE |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | Apr 26, 2001 | SESE |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Standard Imaging, Inc. | Sep 28, 2000 | SESE |
| K943072 | BETA C COUNTER | Capintec Instruments, Inc. | Sep 29, 1994 | SESE |
| K935539 | CAPINTEC CRC 35R | Capintec Instruments, Inc. | Feb 18, 1994 | SESE |
| K931657 | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. | Victoreen, Inc. | Jul 27, 1993 | SESE |
| K905796 | DOSE CALIBRATOR | Capintec Instruments, Inc. | Mar 18, 1991 | SESE |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Atomic Products Corp. | Feb 16, 1989 | SESE |
Top Applicants
- Capintec, Inc. — 6 clearances
- Radcal Corp. — 3 clearances
- Capintec Instruments, Inc. — 3 clearances
- Victoreen, Inc. — 2 clearances
- Sun Nuclear Corp. — 2 clearances
