J.MORITA MFG.CORP.

Address:680 HIGASHIHAMA MINAMI-CHO,,FUSHIMI-KU Kyoto,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (8) Handpiece, Direct Drive, Ac-Powered (EKX) (1) System, X-Ray, Tomography, Computed (JAK) (1)

Premarket Exempt

Clear

ROOT ZX II OTR Module - 04548213022519 Catalog Number :

Device Class : 1

Duns Number: 693811465

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213024698 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213024704 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213024711 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213024728 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213024735 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

3D Accuitomo XYZ Slice View Tomograph - 04548213025046 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : JAK

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213025176 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213025183 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

i-Dixel - 04548213025282 Catalog Number :

Device Class : 2

Duns Number: 693811465

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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