RADQUAL, LLC

RADQUAL, LLC

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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

Phantom, Flood Source, Nuclear (IYQ) (5) Source, Calibration, Sealed, Nuclear (IXD) (5)

Premarket Exempt

Yes

Clear

RadQual - 00850020470006 Catalog Number :

Device Description : Rect 18" x24" Phantom Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IYQ

Prescription Use : No

Device Count : 1

RadQual - 00850020470020 Catalog Number :

Device Description : Rect 14" x 18" Phantom Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IYQ

Prescription Use : No

Device Count : 1

RadQual - 00850020470037 Catalog Number :

Device Description : Square Digirad Phantom Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IYQ

Prescription Use : No

Device Count : 1

RadQual - 00850020470044 Catalog Number :

Device Description : Rect 10" x 16" Phantom Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IYQ

Prescription Use : No

Device Count : 1

RadQual - 00850020470051 Catalog Number :

Device Description : Square 12" x 12" Phantom Co 57

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IYQ

Prescription Use : No

Device Count : 1

RadQual - 00850020470068 Catalog Number :

Device Description : 1" Dia. Al Spot Source Cesium 137

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470075 Catalog Number :

Device Description : 1" Dia. Al Spot Source Sodium 22

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470082 Catalog Number :

Device Description : 1" Dia. Spot Source Cesium 137

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470099 Catalog Number :

Device Description : 1" Dia. Al Spot Source Sodium 22

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

RadQual - 00850020470105 Catalog Number :

Device Description : 1" Dia. Spot Source Sodium w Teflon CT markers

Device Class : 1

Duns Number: 008841076

Premarket Exempt : Yes

Product Code : IXD

Prescription Use : No

Device Count : 1

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