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Sun Nuclear Corporation

United States·US-MF-000021541

Last updated September 18, 2026

About

Sun Nuclear is the source for independent, integrated solutions for Quality Management throughout the diagnosis and treatment of cancer.

From the manufacturer's own website. Source

Information

Country: United States
Address: 900, Asbury Avenue, Norfolk, United States
Website: www.sunnuclear.com
LinkedIn: linkedin.com/company/sun-nuclear-corporation
Facebook: facebook.com/Sun-Nuclear-Corporation-124153101001147
Email: [email protected]
Phone: +16088287000
PRRC Contact: Jeff Shaw
EUDAMED SRN: US-MF-000021541
FDA FEI Number: 1038814
DUNS Number: —

Catalogue (251)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
161B/162A Collimator and Beam Alignment Test Tools	161B/162A	EUDAMED	Class I	Active
Daily QA 4 Pro Wireless	1098	EUDAMED	Class IIb	Active
IQphan	2464	EUDAMED	Class I	Active
Sono404 Small Parts Phantom	404GS LE	EUDAMED	Class I	Active
SunSCAN TPR	1239	EUDAMED	Class I	Active
Solid Water HE	557	EUDAMED	Class I	Active
M3DP, Mammo 3D Performance Kit	M3DP	EUDAMED	Class I	Active
Doppler 403 Flow Phantom	1425B	EUDAMED	Class I	Active
CT ACR 464 Phantom	464	EUDAMED	Class I	Active
CT Perfusion Phantom	432	EUDAMED	Class I	Active
Precision Multi-Purpose Grey Scale Phantom	403GS LE	EUDAMED	Class I	Active
405 GSX Precision Resolution Phantom	405GSXLE	EUDAMED	Class I	Active
Mini-Doppler Flow Phantom	1430 LE	EUDAMED	Class I	Active
SunSCAN Water Resevoir	1238	EUDAMED	Class I	Active
CT Dose Index Phantom	468	EUDAMED	Class I	Active
Mercury 4.0 Phantom	3853	EUDAMED	Class I	Active
CT Sim+	CT Sim+	FDA UDI	Class I	Active
MapPHAN (10cm)	10830001	FDA UDI	Class I	Active
ISORAD Detector, 15-25MV (-) 3m	11640002Z	FDA UDI	Class II	Active
PC Electrometer Reference Class Dual-Channel Electrometer (TNC)	10140001Z	FDA UDI	Class II	Unknown
3d Scanner (bnc)	12300000Z	FDA UDI	Class II	Unknown
Sun Nuclear Advanced Electron Density Phantom	1467	EUDAMEDFDA UDI	Class I	Active
Sun Nuclear MS11 Muscle	452	FDA UDI	Class I	Active
3D Reservoir	1230890Z	FDA UDI	Class II	Active
3D Reservoir	12300002Z	FDA UDI	Class II	Active
3D MiniLift	1231600Z	FDA UDI	Class II	Active
Sun Nuclear CB2 + 10% CaCO3 TMM	483	FDA UDI	Class I	Active
CT Sim	805043	FDA UDI	Class I	Unknown
PC Electrometer Reference Class Dual-Channel Electrometer (BNC)	1014300Z	FDA UDI	Class II	Active
Sun Nuclear CT ACR 464 Phantom	464	FDA UDI	Class I	Active
ArcCHECK	12200000Z	FDA UDI	Class II	Unknown
CT Sim+	CT Sim+	FDA UDI	Class I	Active
QED Detector, Electron (-) 1.5m	11120006Z	FDA UDI	Class II	Active
CT Sim	805142	FDA UDI	Class I	Unknown
CT Sim+	CT Sim+	FDA UDI	Class I	Active
CT Sim+	CT Sim+	FDA UDI	Class I	Active
Reference Detector (bnc)	10460000Z	FDA UDI	Class I	Active
Sun Nuclear SB3 Cortical Bone	450	FDA UDI	Class I	Active
QED Detector, 6-12MV (-) 1.5m	11150006Z	FDA UDI	Class II	Active
Sun Nuclear CT Dose Index	468BH	FDA UDI	Class I	Active
Siemens IMF (Isocentric Mounting Fixture)	1177000SZ	FDA UDI	Class II	Unknown
WaterProof PROFILER	12300009Z	FDA UDI	Class II	Active
Precision Cut EBT3 GafChromic™ Film	158200	FDA UDI	Class I	Unknown
CT Sim	804886	FDA UDI	Class I	Unknown
CT Sim	805428	FDA UDI	Class I	Unknown
MapCHECK2	11770000Z	FDA UDI	Class II	Active
CT Sim	805044	FDA UDI	Class I	Unknown
QED Detector, 6-12MV (+) 3m	11150003Z	FDA UDI	Class II	Active
Elekta IMF (Isocentric Mounting Fixture)	1177000EZ	FDA UDI	Class II	Active
Sun Nuclear CT Electron Density Phantom	467	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Sun Nuclear GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 8, 2014	Z-0959-2015	—	terminated	Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.