CRC-15BT
FDA 510(k) K020150 · Capintec, Inc.
510(k) numberK020150
Submission
- Device name
- CRC-15BT
- Applicant
- Capintec, Inc.
Pittsburgh, PA, US - Received
- January 16, 2002
- Decision date
- August 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K192199 | CRC PC Smart Chamber K1KPT · Special | 09/12/2019SE |
| K162394 | CRC-77tHRKPT · Traditional | 03/08/2017SE |
| K141413 | CRC PC with Smart ChamberKPT · Special | 06/27/2014SE |
| K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special | 08/09/2010SE |
| K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special | 06/28/2007SE |
| K052595 | CRC 15ULTRAJAQ · Traditional | 11/08/2005SE |
| K030175 | 2 BasicIYE · Traditional | 04/17/2003SE |
| K982448 | CardiolightDSH · Traditional | 06/11/1999SE |
| K980402 | Capintec Model 292 ElectrometerIYE · Traditional | 04/24/1998SE |
| K946387 | Capra (Caprac-R) Wipetest and Well CounterJJJ · Traditional | 03/30/1995SE |
Questions and answers
When was CRC-15BT cleared by the FDA?
CRC-15BT (K020150) received a 510(k) decision of Substantially Equivalent on August 2, 2002, 198 days after the submission was received.
What is the product code of K020150?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.