Chrysalis Intelligence · Sponsors · Mirion Technologies (Capintec), Inc.

Mirion Technologies (Capintec), Inc.

Florham Park, NJ, US · 1 510(k) clearances · 4 recalls

Total clearances
1
2026-07-07 → 2026-07-07
Last 12 months
1
Product codes
1
Most recent
2026-07-07
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYT System, Rebreathing, Radionuclide Class II Radiology 1 2026-07-07
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2024-04-22
DateSeverityStatusRecall # ProductCodeReason
2024-04-22 Class II Ongoing Z-1894-2024 Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff… Complaints of unexpected detachment of the collimator have been reported.
2024-04-22 Class II Ongoing Z-1893-2024 Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe t… Complaints of unexpected detachment of the collimator have been reported.
2024-04-22 Class II Ongoing Z-1892-2024 Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. Complaints of unexpected detachment of the collimator have been reported.
2023-11-27 Class II Ongoing Z-1069-2024 Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine P… Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury w…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2026-07-07 K253942 Pulmonex II Xenon System (132-503) IYT Class II Radiology