sunnuclear.comSunCHECK
SUN NUCLEAR CORPORATION
SUN NUCLEAR CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1038814 | 1038814 | SUN NUCLEAR CORPORATION | 1 | N | 2026-01-01 | 3275 Suntree Blvd Melbourne FL US 32940 |
| 1121267 | 1121267 | Sun Nuclear Corporation | 1 | N | 2026-01-01 | 900 Asbury Avenue NORFOLK VA US 23513 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05060608881192 | SunSILICON - The SunSILICON detector is intended for use as a relative dosimetry detector inmeasurements of ionizing radiation emitted from a treatment delivery device. | +1 3212596862 | globalsupport@sunnuclear.com |
| 05060608881208 | SunSILICON P - The SunSILICON P detector is intended for use as a relative dosimetry detector inmeasurements of ionizing radiation emitted from a treatment delivery device. | +1 3212596862 | globalsupport@sunnuclear.com |
| 05060608881499 | RapidCHECK - The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances. | +1 321 259 6862 | GlobalSupport@sunnuclear.com |
| 05060608881574 | Plan AI - Plan AI is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the head and neck, thoracic, abdominal, and pelvic regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists). | +1 321-259-6862 | GLOBALSUPPORT@SUNNUCLEAR.COM |
| 05060608882038 | Capintec NEMA IEC NM Body Phantom - The NEMA IEC Nuclear Medicine Body Phantom is intended to establish, validate and provide for routine and periodic verification of nuclear medicine imaging device consistent with internationally recognized standards. | +1 321-259-6862 | GLOBALSUPPORT@SUNNUCLEAR.COM |
| B136RC10000 | RapidCheck - The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances. | 800-232-9699 | GlobalSupport@sunnuclear.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 98376 | 1882612984 | K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES | IWB | 1991-11-05 |
| 98376 | 1622613125 | K242748 | Oncospace | MUJ | 2025-04-11 |
| 98376 | 1461495480 | K170307 | SunCHECK | IYE | 2017-10-25 |
| 98376 | 1469809003 | K161946 | DoseCHECK | IYE | 2016-09-16 |
| 98376 | 1649767882 | K160057 | ArcCHECK-MR | IYE | 2016-05-13 |
| 98376 | 1301233073 | K150848 | Dose Calculator | IYE | 2015-05-20 |
| 98376 | 1889981887 | K142617 | ArcCHECK | IYE | 2015-11-20 |
| 98376 | 1082967595 | K142431 | WaterProof PROFILER | IYE | 2014-12-05 |
| 98376 | 1707701958 | K142142 | QUALITY REPORTS | IYE | 2014-12-05 |
| 98376 | 1272990366 | K141800 | PERFRACTION | IYE | 2014-09-26 |
| 98376 | 1046080741 | K131862 | 3DVH | IYE | 2013-08-21 |
| 98376 | 1373497504 | K131704 | EPIDOSE | IYE | 2013-08-05 |
| 98376 | 1911781923 | K131466 | MAPCHECK2, ARCCHECK | IYE | 2013-08-20 |
| 98376 | 1574615014 | K112981 | SUN 125C IONIZATION CHAMBER | LHN | 2012-01-25 |
| 98376 | 1438430603 | K101992 | 3D SCANNER, MODEL 1230 | IYE | 2010-10-01 |
| 98376 | 1430674286 | K092019 | MODEL 1014 PC ELECTROMETER | IYE | 2009-09-15 |
| 98376 | 1744754409 | K063021 | PROFILER 2 | IYE | 2006-11-22 |
| 98376 | 1883886650 | K051921 | THE EDGE DETECTOR, MODEL 1118 | IYE | 2005-07-27 |
| 98376 | 1520477450 | K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | LNH | 2001-06-06 |
| 98376 | 1680310259 | K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | IYE | 2001-07-26 |
| 98376 | 2046038671 | K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | IYE | 2001-07-26 |
| 98376 | 1186307538 | ||||
| 29632 | 1256679121 | ||||
| 29632 | 1326131898 | ||||
| 29632 | 1436826609 | ||||
| 98376 | 1582464841 | ||||
| 29632 | 1787960174 | ||||
| 29632 | 1847780040 | ||||
| 98376 | 1877201508 |
Product Codes Associated With Registrations#
PMN#
DoseCHECK
Sun Nuclear Corporation
ArcCHECK-MR
Sun Nuclear Corporation
ArcCHECK
SUN NUCLEAR CORPORATION
Dose Calculator
SUN NUCLEAR CORPORATION
QUALITY REPORTS
SUN NUCLEAR CORPORATION
WaterProof PROFILER
SUN NUCLEAR CORPORATION
PERFRACTION
SUN NUCLEAR CORPORATION
3DVH
SUN NUCLEAR CORPORATION
MAPCHECK2, ARCCHECK
SUN NUCLEAR CORPORATION
EPIDOSE
SUN NUCLEAR CORPORATION
SUN 125C IONIZATION CHAMBER
SUN NUCLEAR CORP.
3D SCANNER, MODEL 1230
SUN NUCLEAR CORP.
MODEL 1014 PC ELECTROMETER
SUN NUCLEAR CORP.
PROFILER 2
SUN NUCLEAR CORP.
THE EDGE DETECTOR, MODEL 1118
SUN NUCLEAR CORP.
RE-ENTRANT CHAMBER
SUN NUCLEAR CORP.
MODEL 1133 IVD PC VERSION
SUN NUCLEAR CORP.
RF-IVD WIRELESS DOSIMETER-MODEL 1133
SUN NUCLEAR CORP.
QED DIODE DETECTORS, MODELS 1112-1116
SUN NUCLEAR CORP.
IVD (IN VIVO DOSIMETER), MODEL 1131
SUN NUCLEAR CORP.
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
SUN NUCLEAR CORP.
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206
SUN NUCLEAR CORP.
CAL/RAD UPGRADE MODEL 1030
SUN NUCLEAR CORP.
GUDID#
RapidCHECK - The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances.
2026-05-10
RapidCheck - The RapidCHECK platform is intended for supporting users in analyzing diagnostic imaging data to ensure the performance of the diagnostic system is operating within safe and expected tolerances.
2018-11-28
Daily QA™ 4 Pro Wireless - Model 1098 is intended to measure and analyze daily radiation output and positioning characteristics of a Cobalt 60 or LINAC Treatment Delivery Device before the start of daily treatment in a radiation oncology center and not for calibration of said machines.
2026-02-24
Daily QA™ 4 Pro - Model 1098 is intended to measure and analyze daily radiation output and positioning characteristics of a Cobalt 60 or LINAC Treatment Delivery Device before the start of daily treatment in a radiation oncology center and not for calibration of said machines.
2026-02-24
Capintec NEMA IEC NM Body Phantom - The NEMA IEC Nuclear Medicine Body Phantom is intended to establish, validate and provide for routine and periodic verification of nuclear medicine imaging device consistent with internationally recognized standards.
2025-11-07
Plan AI - Plan AI is used to configure and review radiotherapy treatment plans for a patient with malignant or benign disease in the head and neck, thoracic, abdominal, and pelvic regions. It allows for set up of radiotherapy treatment protocols, association of a potential treatment plan with the protocol(s), submission of a dose prescription and achievable dosimetric goals to a treatment planning system, and review of the treatment plan. It is intended for use by qualified, trained radiation therapy professionals (such as medical physicists, oncologists, and dosimetrists).
2025-11-07
SunSILICON P - The SunSILICON P detector is intended for use as a relative dosimetry detector inmeasurements of ionizing radiation emitted from a treatment delivery device.
2025-07-08
SunSILICON - The SunSILICON detector is intended for use as a relative dosimetry detector inmeasurements of ionizing radiation emitted from a treatment delivery device.
2025-07-08
Precision Cut GafChromic™ Film - Radiographic film
2024-11-01
Precision Cut EBT3 GafChromic™ Film - 158200
2024-01-02
SRS PROFILER - Radiotherapeutic quality assurance instrument
2019-09-17
SunSCAN 3D - The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a Treatment Planning System (TPS) computer. It is also intended for periodic beam Quality Assurance (QA) tests as defined by the medical physicist responsible for the QA program.
2023-06-08
SunSCAN 3D - The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a Treatment Planning System (TPS) computer. It is also intended for periodic beam Quality Assurance (QA) tests as defined by the medical physicist responsible for the QA program.
2023-06-08
CT Sim - Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim is intended to read laser positioning coordinates in a specified file format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim - Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim is intended to read laser positioning coordinates in a specified file format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim - 805044
2016-09-23
CT Sim - Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim is intended to read laser positioning coordinates in a specified file format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim - Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim is intended to read laser positioning coordinates in a specified file format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim - Gammex CT Sim Laser systems are used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim is intended to read laser positioning coordinates in a specified file format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 5-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2017-10-26
CT Sim+ - The CT Sim+, 5-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System
2017-10-26
CT Sim+ - The CT Sim+, 5-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2017-10-26
CT Sim+ - The CT Sim+, 3-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 3-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 3-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2017-08-14
CT Sim+ - The CT Sim+, 1-Arm, Red Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2017-08-14
CT Sim+ - The CT Sim+, 1-Arm, Green Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
CT Sim+ - The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2017-08-14
CT Sim+ - The CT Sim+, 1-Arm, Blue Laser is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the radiation treatment isocenter or can be used to define the center of the CT imager. The Gammex CT Sim+ is intended to read laser positioning coordinates in a DICOM or Gammex specified software format. Typically the coordinates are calculated by a Radiation Therapy Treatment Planning System (RTPS) or CT Virtual Simulation System.
2016-09-23
Sun Nuclear MICRO+ MR - The MICRO+ MR MLR+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ - The MICRO+ MLR+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ MR - The MICRO+ MR MLR+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ - The MICRO+ MLR+300 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO - The MICRO MLR 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO - The MICRO MLR 150 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ MR - The MICRO+ MR MLG+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ - The MICRO+ MLG+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25
Sun Nuclear MICRO+ MR - The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. This product is used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
2021-01-25