Dose Calibrator
FDA 510(k) K905796 · Capintec Instruments, Inc.
510(k) numberK905796
Submission
- Device name
- Dose Calibrator
- Applicant
- Capintec Instruments, Inc.
Pittsburgh, PA, US - Received
- December 27, 1990
- Decision date
- March 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K192199 | CRC PC Smart Chamber K1KPT · Special | Capintec, Inc. | 09/12/2019SE |
| K162394 | CRC-77tHRKPT · Traditional | Capintec, Inc. | 03/08/2017SE |
| K142325 | Veenstra Instruments VDC-506 Dose CalibratorKPT · Special | Comecer Netherlands B.V. | 09/18/2014SE |
| K141413 | CRC PC with Smart ChamberKPT · Special | Capintec, Inc. | 06/27/2014SE |
| K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special | Capintec, Inc. | 08/09/2010SE |
| K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336KPT · Traditional | Biodex Medical Systems, Inc. | 02/19/2009SE |
| K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special | Capintec, Inc. | 06/28/2007SE |
| K042746 | Pet-DoseKPT · Traditional | Comecer S.R.L. | 11/22/2004SE |
| K030066 | Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165KPT · Traditional | Nuclear Associates | 08/29/2003SE |
| K011493 | Mentor Isoloader Automatic Needle Loading System and Physics Workstation for BrachytherapyKPT · Traditional | Mentor Corp. | 10/01/2002SE |
More from Mentor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K943072 | Beta C CounterKPT · Traditional | 09/29/1994SE |
| K935539 | Capintec CRC 35RKPT · Traditional | 02/18/1994SE |
| K930962 | Captus 2000 Wel CounterIZD · Traditional | 05/18/1993SE |
| K924586 | Captus 500 Well Detector W/Clinical Labor SoftwareIZD · Traditional | 12/03/1992SE |
| K921428 | Captus 500IZD · Traditional | 05/28/1992SE |
| K910020 | Capintec Thyroid Uptake System-Various ModelsIZO · Traditional | 04/08/1991SE |
Questions and answers
When was Dose Calibrator cleared by the FDA?
Dose Calibrator (K905796) received a 510(k) decision of Substantially Equivalent on March 18, 1991, 81 days after the submission was received.
What is the product code of K905796?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.