RADIADYNE, L.L.C.

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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

Dosimeter, Ionizing Radiation, Implanted (NZT) (8) Prostate Immobilizer Rectal Balloon (PCT) (2)

Premarket Exempt

Clear

IsoLoc - 00851546007103 Catalog Number : ISO-100

Device Description : IsoLoc Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

Photon MicroPSD - 00851546007141 Catalog Number : PSD-PE5N

Device Description : Photon-calibrated microPSD sensor cable

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

QC MicroPSD - 00851546007158 Catalog Number : PSD-QE5N

Device Description : QC-calibrated microPSD sensor cable

Device Class :

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

QC microPSD - 00851546007165 Catalog Number : PSD-QC5N

Device Description : QC microPSD sensor cable

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

OARtrac - 00851546007196 Catalog Number : OT-CDU2P

Device Description : OARtrac Plus Clinical Detector Unit (CDU)

Device Class :

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : No

Device Count : 1

IsoLoc - 00851546007219 Catalog Number : ISO-60

Device Description : IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : PCT

Prescription Use : Yes

Device Count : 1

Photon microPSD - 00851546007417 Catalog Number : PSD-PE5N

Device Description : Photon calibrated non-sterile microPSD sensor cable.

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

QC microPSD - 00851546007516 Catalog Number : PSD-QE5N

Device Description : QC calibrated microPSD sensor cable

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

Electron microPSD - 00851546007615 Catalog Number : PSD-EE5N

Device Description : Electron non-sterile microPSD sensor cable

Device Class : 2

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

HDR microPSD - 00851546007714 Catalog Number : PSD-HB5N

Device Description : HDR Brachy calibrated non-sterile microPSD sensor cable

Device Class :

Duns Number: 005744772

Premarket Exempt : No

Product Code : NZT

Prescription Use : Yes

Device Count : 1

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