510(k) K192196 ยท IYE Accelerator, Linear, Medical
Medical Radiation Dosimetry System microSTARii
| Applicant | Landauer, Glenwood IL, US |
| Decision | Substantially Equivalent, Dec 27, 2019 |
| Received | Aug 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192196
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2023 | Landauer Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 03051-1MO;
b) 03051-3MO;
c) 03051-OTO;
d) 03051-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 03053-1MO;
b) 03053-1WK ;
c) 03053-3MO;
d) 03053-OTO;
e) 03053-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03055-1MO;
b) 03055-3MO;
c) 03055-OTO;
d) 03055-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03056-000 (EMEA number VINLNAN002);
b) 03056-1MO;
c) 03056-3MO;
d) 03056-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 03057-1MO;
b) 03057-3MO;
c) 03057-OTO;
d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DXN, Model Numbers:
a) 03060-1MO;
b) 03060-3MO;
c) 03060-OTO;
d) 03060-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DXN, Model Numbers:
a) 03061-1MO;
b) 03061-3MO;
c) 03061-OTO;
d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DXS, Model Numbers:
a) 03062-1MO;
b) 03062-3MO;
c) 03062-OTO;
d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DXS, Model Numbers:
a) 03063-1MO;
b) 03063-3MO;
c) 03063-OTO;
d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04217-000 (EMEA number VINLNAN003);
b) 04217-KIT;
c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 04218-000 (EMEA number VINLNAN004);
b) 04218-KIT;
c) 04218-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04224-000 (EMEA number VINLNAN006);
b) 04224-KIT;
c) 04224-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 04225-000 (EMEA number VINLNAN005);
b) 04225-KIT;
c) 04225-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNN , Model Numbers:
a) 04293-000;
b) 04293-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNS, Model Numbers:
a) 18100-000;
b) 18100-1MO;
c) 18100-2MO;
d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer nanoDot D2DNN, Model Numbers:
a) 18105-000;
b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18120-000;
b) 18120-KIT;
c) 18120-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18121-000;
b)18121-KIT;
c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18125-000;
b) 18125-KIT;
c) 18125-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18130-000;
b) 18130-KIT;
c) 18130-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (80 kVp) nanoDot D2DNS, Model Numbers:
a) 18131-000;
b) 18131-KIT;
c) 18131-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer QC (Cs-137) nanoDot D2DNS, Model Numbers:
a) 18135-000;
b) 18135-KIT;
c) 18135-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Calibrate (unexposed) nanoDot D2DNS, Model Numbers:
a) 18140-000;
b) 18140-KIT;
c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Constancy (80 kVp) nanoDot D2DNN, Model Numbers:
a) 18150-000 (EMEA number VKITCON002);
b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Constancy (Cs-137) nanoDot D2DNN, Model Numbers:
a) 18155-000 (EMEA number VKITCON001);
b) 18155-KIT; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer NanoDots, Model Numbers:
a) BC30023, description: QC Set For Microstar Dots;
b) BC30083, description: nanoDot QC Set - 80kVp - Sale;
c) BC30084, description: nanoDot QC Set - 80kVp - No Charge; Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
| Sep 12, 2023 | Landauer Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers Completed |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.