Dosimeter, Ionizing Radiation, Implanted
Regulation 892.5050
0510(k)s in 12 months (7 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in NZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Angiodynamics, Inc. | 0 | 5 |
| Radiadyne | 3 | 0 |
| Sicel Technologies, Inc. | 2 | 0 |
| Nu-Rise, SA | 1 | 0 |
| Radialdyne, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2019 | Angiodynamics, Inc. MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as a Terminated |
NZT | K182395 |
| Nov 19, 2019 | Angiodynamics, Inc. MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to trea Terminated |
NZT | K182395 |
| Nov 19, 2019 | Angiodynamics, Inc. MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to Terminated |
NZT | K182395 |
| Nov 19, 2019 | Angiodynamics, Inc. OARtrac PLUS CLINICAL DETECTOR UNIT
Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation thera Terminated |
NZT | K182395 |
| Nov 19, 2019 | Angiodynamics, Inc. OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL
BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and e Terminated |
NZT | K182395 |
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