Calibrator, Dose, Radionuclide
Regulation 892.1360
0510(k)s in 12 months (32 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in KPT
| Company | 510(k)s | Recalls |
|---|---|---|
| Capintec, Inc. | 6 | 2 |
| Biodex Medical Systems, Inc. | 1 | 2 |
| Capintec Instruments, Inc. | 3 | 0 |
| Radcal Corp. | 3 | 0 |
| Clinicomp, Inc. | 2 | 0 |
| Standard Imaging, Inc. | 2 | 0 |
| Sun Nuclear Corp. | 2 | 0 |
| Victoreen, Inc. | 2 | 0 |
| Atomic Products Corp. | 1 | 0 |
| Comecer Netherlands B.V. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2021 | Biodex Medical Systems, Inc. AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive
Model: 086-332 Terminated |
KPT | K090296 |
| Aug 16, 2021 | Biodex Medical Systems, Inc. Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive
Model: 086-330. Terminated |
KPT | K090296 |
| Nov 9, 2011 | Capintec Inc Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02
PET dose calibrator Terminated |
KPT | K071396 |
| Oct 28, 2010 | Capintec Inc Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA. Terminated |
KPT | None listed |
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