Atlas FDA

Medical Radiation Dosimetry System microSTARii

FDA 510(k) clearance K192196 · decided 2019-12-27

Clearance details

K-number
K192196
Device name
Medical Radiation Dosimetry System microSTARii
Applicant
Landauer
Decision
Substantially Equivalent
Date received
2019-08-13
Decision date
2019-12-27
Days to decision
136 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Glenwood, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/ recall (Z-0616-2024)Landauer2023-12-22
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dos recall (Z-2538-2023)Landauer2023-09-12
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring do recall (Z-2539-2023)Landauer2023-09-12
nanoDot D2DNN, Model Numbers: a) 03051-1MO; b) 03051-3MO; c) 03051-OTO; d) 03051-SMO; radi recall (Z-2540-2023)Landauer2023-09-12
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) recall (Z-2541-2023)Landauer2023-09-12
nanoDot D2DNS, Model Numbers: a) 03055-1MO; b) 03055-3MO; c) 03055-OTO; d) 03055-SMO; radi recall (Z-2542-2023)Landauer2023-09-12
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 0305 recall (Z-2543-2023)Landauer2023-09-12
nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radi recall (Z-2544-2023)Landauer2023-09-12
nanoDot D2DXN, Model Numbers: a) 03060-1MO; b) 03060-3MO; c) 03060-OTO; d) 03060-SMO; radi recall (Z-2545-2023)Landauer2023-09-12
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radi recall (Z-2546-2023)Landauer2023-09-12
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radi recall (Z-2547-2023)Landauer2023-09-12
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radi recall (Z-2548-2023)Landauer2023-09-12
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring do recall (Z-2549-2023)Landauer2023-09-12
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring do recall (Z-2550-2023)Landauer2023-09-12
QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitoring dosimeter recall (Z-2551-2023)Landauer2023-09-12
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter recall (Z-2552-2023)Landauer2023-09-12
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosim recall (Z-2553-2023)Landauer2023-09-12
nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosime recall (Z-2554-2023)Landauer2023-09-12
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosime recall (Z-2555-2023)Landauer2023-09-12
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosime recall (Z-2556-2023)Landauer2023-09-12
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) recall (Z-2557-2023)Landauer2023-09-12
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNAN004); b) 04218- recall (Z-2558-2023)Landauer2023-09-12
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) recall (Z-2559-2023)Landauer2023-09-12
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225- recall (Z-2560-2023)Landauer2023-09-12
nanoDot D2DNN , Model Numbers: a) 04293-000; b) 04293-KIT; radiation monitoring dosimeter recall (Z-2561-2023)Landauer2023-09-12
nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radi recall (Z-2562-2023)Landauer2023-09-12
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter u recall (Z-2563-2023)Landauer2023-09-12
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; recall (Z-2564-2023)Landauer2023-09-12
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; recall (Z-2565-2023)Landauer2023-09-12
Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-KIT; c) 18125-SET; recall (Z-2566-2023)Landauer2023-09-12
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiat recall (Z-2567-2023)Landauer2023-09-12
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiat recall (Z-2568-2023)Landauer2023-09-12
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiat recall (Z-2569-2023)Landauer2023-09-12
Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-S recall (Z-2570-2023)Landauer2023-09-12
Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) recall (Z-2571-2023)Landauer2023-09-12
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) recall (Z-2572-2023)Landauer2023-09-12
NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Dots; b) BC30083, d recall (Z-2573-2023)Landauer2023-09-12
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR r recall (Z-2574-2023)Landauer2023-09-12
Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used w recall (Z-2575-2023)Landauer2023-09-12