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465
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Manufacturers
JP
Shimadzu Corporation Medical Systems Division
Medical Device Manufacturer
·
JP , Kyoto
Shimadzu Corporation Medical Systems Division - FDA 510(k) Cleared De...
2 submissions
·
2 cleared
·
Since 2022
Recent clearances:
SET-5002
,
Trinias
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shimadzu Corporation Medical Systems Division
Radiology
✕
2
devices
1-2 of 2
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Cleared
May 24, 2024
SET-5002
K240827
·
KPS
Radiology
·
59d
Cleared
Jul 28, 2022
Trinias
K221922
·
OWB
Radiology
·
27d
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Radiology
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