Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW
FDA 510(k) K101452 · Capintec, Inc.
510(k) numberK101452
Submission
- Device name
- Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW
- Applicant
- Capintec, Inc.
Pittsburgh, PA, US - Received
- May 25, 2010
- Decision date
- August 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K020150 | CRC-15BTKPT · Traditional | Capintec, Inc. | 08/02/2002SE |
More from Capintec, Inc.
| 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 |
| 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 |
| K020150 | CRC-15BTKPT · Traditional | 08/02/2002SE |
| 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 Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW cleared by the FDA?
Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW (K101452) received a 510(k) decision of Substantially Equivalent on August 9, 2010, 76 days after the submission was received.
What is the product code of K101452?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.