SUN NUCLEAR CORP.

Address:3275 Suntree Blvd,Melbourne,FL,32940,US

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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

Accelerator, Linear, Medical (IYE) (6) System, Nuclear Magnetic Resonance Imaging (LNH) (4)

Premarket Exempt

No Yes

Clear

3D MiniLift - 05060608880324 Catalog Number : 1230000-3Z

Device Description : Accessory to the 3D SCANNER Radiation therapy QA device

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

3D Reservoir - 05060608880331 Catalog Number : 12300002Z

Device Description : Accessory to the 1230 3D SCANNER.

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

SunCHECK - 05060608880348 Catalog Number : 1299000-0

Device Description : SunCHECK is a software platform intended to collect, detect, compare, calculate, SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts.

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

ArcCHECK-MR - 05060608880355 Catalog Number : 12200000MR

Device Description : Radiation therapy QA device.

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

3D SCANNER (TNC) - 05060608880362 Catalog Number : 1231900Z

Device Description : Radiation therapy QA device.

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

3DVH - 05060608880379 Catalog Number : 1212

Device Description : Radiation therapy QA device.

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : IYE

Prescription Use : Yes

Device Count : 1

QED Detector, Electron (-) 3m - 05060608880386 Catalog Number : 11120002Z

Device Description : Radiation therapy QA device

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

QED Detector, Electron (+) 3m - 05060608880393 Catalog Number : 11120003Z

Device Description : Radiation therapy QA device

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

QED Detector, Electron (-) 1.5m - 05060608880409 Catalog Number : 11120006Z

Device Description : Radiation therapy QA device

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

QED Detector, Skin (-) 3m - 05060608880416 Catalog Number : 11130002Z

Device Description : Radiation therapy QA device

Device Class : 2

Duns Number: 122240021

Premarket Exempt : No

Product Code : LNH

Prescription Use : Yes

Device Count : 1

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