Company ยท US
Mirion Technologies (Capintec), Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2026 to 2026. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (1 in 12 months)
5recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| 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 |