Data / Medical devices / United States / Sun Nuclear Corporation

Sun Nuclear Corporation: FDA-registered device maker in Melbourne, FL, United States, 19 510(k) clearances

Name: Sun Nuclear Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sun Nuclear Corporation is registered with the FDA (registration 1038814) in Melbourne, FL, United States. It lists 8 device types. The FDA files 19 510(k) clearances under its listings, the newest dated April 11, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Sun Nuclear Corporation

FDA registration number: 1038814
Address: 3275 Suntree Blvd, Melbourne, FL, United States, 32940
Owner or operator: SUN NUCLEAR CORPORATION (10028193)
Roles: Complaint file establishment, Manufacturer
First device listed: January 7, 2009
Registered through: 2026
Brand names listed: 1014 - PC Electrometer, 1041 - SNC125c, 1045 - SNC350p, 1046 - Reference Detector, 1047 - SNC600c, 1048 - SunSILICON, 1049 - SunSILICON P, 1057 - Plan AI and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Manufacturer	accessdata.fda.gov
Monitor, Patient Position, Light-Beam	IWE	1	Complaint file establishment	accessdata.fda.gov
Phantom, Anthropomorphic, Radiographic	IXG	1	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Radionuclide	IWB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 11, 2025	K242748	Oncospace	MUJ	Substantially Equivalent	Oncospace, Inc.	accessdata.fda.gov
October 25, 2017	K170307	SunCHECK	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
September 16, 2016	K161946	DoseCHECK	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
May 13, 2016	K160057	ArcCHECK-MR	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
November 20, 2015	K142617	ArcCHECK	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
May 20, 2015	K150848	Dose Calculator	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
December 5, 2014	K142431	WaterProof PROFILER	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
December 5, 2014	K142142	QUALITY REPORTS	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
September 26, 2014	K141800	PERFRACTION	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
August 21, 2013	K131862	3DVH	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
August 20, 2013	K131466	MAPCHECK2, ARCCHECK	IYE	Substantially Equivalent	Sun Nuclear Corporation	accessdata.fda.gov
January 25, 2012	K112981	SUN 125C IONIZATION CHAMBER	LHN	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
October 1, 2010	K101992	3D SCANNER, MODEL 1230	IYE	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
September 15, 2009	K092019	MODEL 1014 PC ELECTROMETER	IYE	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
November 22, 2006	K063021	PROFILER 2	IYE	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
July 27, 2005	K051921	THE EDGE DETECTOR, MODEL 1118	IYE	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
July 26, 2001	K011332	RF-IVD WIRELESS DOSIMETER-MODEL 1133	IYE	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
June 6, 2001	K011466	QED DIODE DETECTORS, MODELS 1112-1116	LNH	Substantially Equivalent	Sun Nuclear Corp.	accessdata.fda.gov
November 5, 1991	K912250	ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES	IWB	Substantially Equivalent	Theta Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2014	69751	Class II	Terminated	IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.	Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.	accessdata.fda.gov

Compare with other makers

Updated April 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.