GAMMEX, INC.

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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

Instrument, Quality-Assurance, Radiologic (LHO) (10)

Premarket Exempt

No Yes

Clear

Sun Nuclear Original Solid Water - B1364570 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CT ACR 464 Phantom - B1364640 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CT Electron Density Phantom - B1364670 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CT Dose Index - B136468BH0 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CT Dose Index Phantom - B136468BHP0 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CB2 + 50% CaCO3 - B1364800 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear BRN-SR2 Brain - B1364810 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear LV1 Liver TMM - B1364820 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CB2 + 10% CaCO3 TMM - B1364830 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

Sun Nuclear CB2 + 30% CaCO3 TMM - B1364840 Catalog Number :

Device Class : 1

Duns Number: 157308230

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : Yes

Device Count : 1

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