510(k) K182395 ยท NZT Dosimeter, Ionizing Radiation, Implanted
OARtrac System
| Applicant | Radialdyne, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Mar 22, 2019 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.