Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1360](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1360) → KPT — Calibrator, Dose, Radionuclide # KPT · Calibrator, Dose, Radionuclide _Radiology · 21 CFR 892.1360 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT ## Overview - **Product Code:** KPT - **Device Name:** Calibrator, Dose, Radionuclide - **Regulation:** [21 CFR 892.1360](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1360) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K192199.md) | CRC PC Smart Chamber K1 | Capintec, Inc. | Sep 12, 2019 | SESE | | [K162394](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K162394.md) | CRC-77tHR | Capintec, Inc. | Mar 8, 2017 | SESE | | [K142325](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K142325.md) | Veenstra Instruments VDC-506 Dose Calibrator | Comecer Netherlands B.V. | Sep 18, 2014 | SESE | | [K141413](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K141413.md) | CRC PC WITH SMART CHAMBER | Capintec, Inc. | Jun 27, 2014 | SESE | | [K101452](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K101452.md) | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | Capintec, Inc. | Aug 9, 2010 | SESE | | [K090296](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K090296.md) | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | Biodex Medical Systems, Inc. | Feb 19, 2009 | SESE | | [K071396](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K071396.md) | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | Capintec, Inc. | Jun 28, 2007 | SESE | | [K042746](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K042746.md) | PET-DOSE | Comecer S.R.L. | Nov 22, 2004 | SESE | | [K030066](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K030066.md) | CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 | Nuclear Associates | Aug 29, 2003 | SESE | | [K011493](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K011493.md) | MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY | Mentor Corp. | Oct 1, 2002 | SESE | | [K020150](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K020150.md) | CRC-15BT | Capintec, Inc. | Aug 2, 2002 | SESE | | [K013689](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K013689.md) | RE-ENTRANT CHAMBER | Sun Nuclear Corp. | Jul 2, 2002 | SESE | | [K013548](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K013548.md) | STANDARD IMAGING IVB 1000 WELL CHAMBER | Standard Imaging, Inc. | Nov 9, 2001 | SESE | | [K010417](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K010417.md) | CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 | Nuclear Assoc., Div. Inovision LP | Apr 26, 2001 | SESE | | [K002833](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K002833.md) | MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER | Standard Imaging, Inc. | Sep 28, 2000 | SESE | | [K943072](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K943072.md) | BETA C COUNTER | Capintec Instruments, Inc. | Sep 29, 1994 | SESE | | [K935539](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K935539.md) | CAPINTEC CRC 35R | Capintec Instruments, Inc. | Feb 18, 1994 | SESE | | [K931657](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K931657.md) | NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. | Victoreen, Inc. | Jul 27, 1993 | SESE | | [K905796](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K905796.md) | DOSE CALIBRATOR | Capintec Instruments, Inc. | Mar 18, 1991 | SESE | | [K884312](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT/K884312.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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