FDA Product Code
FDA Product Code KPT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1360
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1 | Capintec, Inc. | 2019-09-12 | Special | PDF ↗ |
| K162394 | CRC-77tHR | Capintec, Inc. | 2017-03-08 | Traditional | PDF ↗ |
| K142325 | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | 2014-09-18 | Special | PDF ↗ |
| K141413 | CRC PC WITH SMART CHAMBER | Capintec, Inc. | 2014-06-27 | Special | PDF ↗ |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Capintec, Inc. | 2010-08-09 | Special | PDF ↗ |
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Biodex Medical Systems, Inc. | 2009-02-19 | Traditional | PDF ↗ |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | 2007-06-28 | Special | PDF ↗ |
| K042746 | PET-DOSE | Comecer S.R.L. | 2004-11-22 | Traditional | PDF ↗ |
| K030066 | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | Nuclear Associates | 2003-08-29 | Traditional | PDF ↗ |
| K011493 | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Mentor Corp. | 2002-10-01 | Traditional | PDF ↗ |
| K020150 | CRC-15BT | Capintec, Inc. | 2002-08-02 | Traditional | PDF ↗ |
| K013689 | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | 2002-07-02 | Traditional | PDF ↗ |
| K013548 | STANDARD IMAGING IVB 1000 WELL CHAMBER | Standard Imaging, Inc. | 2001-11-09 | Special | PDF ↗ |
| K010417 | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | 2001-04-26 | Traditional | PDF ↗ |
| K002833 | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Standard Imaging, Inc. | 2000-09-28 | Special | PDF ↗ |
| K943072 | BETA C COUNTER | Capintec Instruments, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K935539 | CAPINTEC CRC 35R | Capintec Instruments, Inc. | 1994-02-18 | Traditional | PDF ↗ |
| K931657 | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. | Victoreen, Inc. | 1993-07-27 | Traditional | PDF ↗ |
| K905796 | DOSE CALIBRATOR | Capintec Instruments, Inc. | 1991-03-18 | Traditional | PDF ↗ |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | Atomic Products Corp. | 1989-02-16 | Traditional | PDF ↗ |
| K880272 | CAL/RAD UPGRADE MODEL 1030 | Sun Nuclear Corp. | 1988-02-29 | Traditional | PDF ↗ |
| K850838 | CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW | Clinicomp, Inc. | 1985-09-26 | Traditional | PDF ↗ |
| K850815 | RADIOISOTOPE CALIBRATOR MODEL 34-062 | Victoreen, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K842540 | CLINICOMP R.C.I. | Clinicomp, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K842570 | LUDLUM 88 DOSE CALIBRATOR | Ludlum Measurements, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K841786 | RADCAL MODEL 4051 RADIONUCLIDE CALIBRA | Radcal Corp. | 1984-07-16 | Traditional | PDF ↗ |
| K841787 | RADCAL MODEL 4050 RADIONUCLIDE CALIB | Radcal Corp. | 1984-07-16 | Traditional | PDF ↗ |
| K841785 | RADCAL MODEL 4046 RADIONUCLIDE CALIBR | Radcal Corp. | 1984-07-16 | Traditional | PDF ↗ |
| K813379 | RADIONUCLIDE DOSE CALIBRATOR | Medi Nuclear Corp., Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K813065 | B.D.A.S. | General Electric Co. | 1981-12-08 | Traditional | PDF ↗ |
| K811320 | CAL-3 CALIBRATED RADIOACTIVITY ASSAYER | Dosimeter Corp. | 1981-06-02 | Traditional | PDF ↗ |
| K770515 | DISPENSER, TECHNETIUM, CLINTICHEM | Union Carbide Corp. | 1977-04-05 | Traditional | PDF ↗ |
Product code KPT · Class II · Radiology. Data: openFDA.