Probe, Uptake, Nuclear
Regulation 892.1320
0510(k)s in 12 months (30 all time)
1recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in IZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Mirion Technologies (Capintec), Inc. | 0 | 5 |
| Neoprobe Corp. | 5 | 0 |
| Capintec Inc | 0 | 4 |
| Care Wise Medical Products Corp. | 4 | 0 |
| Capintec Instruments, Inc. | 3 | 0 |
| Surgiceye GmbH | 3 | 0 |
| Medimatic | 2 | 0 |
| Nuclear Data, Inc. | 2 | 0 |
| Oakfield Instruments, Ltd. | 2 | 0 |
| Radiation Monitoring Devices, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154; Open, Classified |
IZD | None listed |
| May 24, 2024 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. Open, Classified |
IZD | None listed |
| May 24, 2024 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. Open, Classified |
IZD | None listed |
| May 24, 2024 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. Open, Classified |
IZD | None listed |
| Feb 9, 2024 | Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
Models: 5430-30151, 5430-30152, Open, Classified |
IZD | None listed |
| Sep 7, 2020 | Devicor Medical Products Inc Neoprobe GDS Control Unit, Model Number NPCU3 Terminated |
IZD | None listed |
| Mar 24, 2020 | Capintec Inc Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Terminated |
IZD | None listed |
| Dec 4, 2018 | Capintec Inc Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 Terminated |
IZD | None listed |
| Dec 4, 2018 | Capintec Inc Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 Terminated |
IZD | None listed |
| Sep 5, 2012 | Capintec Inc Capintec Captus 3000 Thyroid Uptake System
Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement o Terminated |
IZD | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.