Radcal Model 4050 Radionuclide Calib
FDA 510(k) K841787 · Radcal Corp.
510(k) numberK841787
Submission
- Device name
- Radcal Model 4050 Radionuclide Calib
- Applicant
- Radcal Corp.
Mchenry, IL, US - Received
- April 30, 1984
- Decision date
- July 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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.
Questions and answers
When was Radcal Model 4050 Radionuclide Calib cleared by the FDA?
Radcal Model 4050 Radionuclide Calib (K841787) received a 510(k) decision of Substantially Equivalent on July 16, 1984, 77 days after the submission was received.
What is the product code of K841787?
The FDA product code is KPT – Calibrator, Dose, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1360.