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Calibrator, Dose, Radionuclide
FDA product code KPT · Class 2 · Radiology
23
Registered devices
1
Adverse events
4
Recalls
32
510(k) clearances
Devices with this code
Atomlab 500 Plus — BIODEX MEDICAL SYSTEMS, INC.TheraSeed — THERAGENICS CORPORATIONCapintec Dose Calibrator — Mirion Technologies (capintec), Inc.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.IBC-Lite — Comecer Netherlands B.V.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.TheraSeed — THERAGENICS CORPORATIONAtomlab Dose Calibrator — BIODEX MEDICAL SYSTEMS, INC.Standard Imaging HDR 1000 Plus — STANDARD IMAGING INC.VIK203 — Comecer Netherlands B.V.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.I-Seed Agx100 — THERAGENICS CORPORATIONStandard Imaging IVB 1000 Well Chamber — STANDARD IMAGING INC.I-Seed Agx100 — THERAGENICS CORPORATIONAtomlab 500 Dose Calibrator — BIODEX MEDICAL SYSTEMS, INC.VDC606 — Comecer Netherlands B.V.Atomlab Wipe Test Counter — BIODEX MEDICAL SYSTEMS, INC.Capintec Dose Calibrator — Mirion Technologies (capintec), Inc.VIK202 — Comecer Netherlands B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-16 | Biodex Medical Systems, Inc. | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes |
| 2021-08-16 | Biodex Medical Systems, Inc. | When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes |
| 2011-07-08 | Capintec Inc | Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET |
| 2010-09-20 | Capintec Inc | The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the col |
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