SUN NUCLEAR CORPORATION

FDA Device Registration & Listing · Melbourne, FL, US · Registration 1038814

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1038814
FEI Number
1038814
Entity Name
SUN NUCLEAR CORPORATION
City/State/Country
Melbourne, FL, US
Establishment Address
3275 Suntree Blvd, Melbourne, FL 32940, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SUN NUCLEAR CORPORATION (Owner Number: 10028193)
Owner / Operator Contact Address
3275 Suntree Boulevard, Melbourne, FL 32940, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K101992
PMA Number
N/A

All Registered Proprietary Names

1049 - SunSILICON P 1048 - SunSILICON 1118 - EDGE DETECTOR 1057 - Plan AI 1178 - MapCHECK 3 1179 - SRS MapCHECK 1215 - PerFRACTION 1136 - rf-IVD (WIRELESS) 1014 - PC Electrometer 1220 - ArcCHECK 1299 - SunCHECK MICRO+ MICRO CT SIM+ 1203 - WaterProof PROFILER 1216 - PlanIQ 1218 - Dose Calculator 1174 - PROFILER2 1137 - IVD (WIRED) 1162 - ISORAD 1164 - ISORAD 1163 - ISORAD 1230 - 3D SCANNER 1234/1235 - SunSCAN 3D

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-01-07
MUJ System, Planning, Radiation Therapy Treatment Radiology Class 2 892.5050 2025-05-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2013-08-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-10-21
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-01-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-09-17
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2016-06-23
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2017-11-01
IWE Monitor, Patient Position, Light-Beam Radiology Class 1 892.5780 2024-11-14
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-12-08
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2014-12-08
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-12-18
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-01-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-01-07
IWB System, Radiation Therapy, Radionuclide Radiology Class 2 892.5750 2009-01-07
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2010-10-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUN NUCLEAR CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1121267 Sun Nuclear Corporation NORFOLK, VA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
K993675 Nomos Corp. PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM 2000-09-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1038814. Last updated year: 2026. Please use registration number 1038814 when referencing this establishment in official correspondence.
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