Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2411512

FEI Number

2411512

Entity Name

E-Z-EM, INC.

City/State/Country

Princeton, NJ, US

Establishment Address

510 Carnegie Center, Princeton, NJ 08540, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Bracco Diagnostics Inc. (Owner Number: 2411512)

Owner / Operator Contact Address

510 Carnegie Center, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K030854

PMA Number

N/A

All Registered Proprietary Names

LIQUID MEDICATION DISPENSER HeartSee Cardiac P.E.T.Processing Software CYSTO-AID (TM) VOIDING AID CYSTO AID Transpec Specimen Radiography Device E-Z Mark Vented Cap/Waste Bottle use with CardioGen-82 Infusion Syste Waste Bottle for use with CardioGen-82 Infusion System Elution Test Vial Bottle use with CardioGen-82 Infusion Syst Elution Test Vial Shield use with CardioGen-82 Infusion Syst Accessory Package for use with CardioGen-82 Infusion System Patient Administration Set for CardioGen-82 Infusion System Protocol Insufflator VC Administration Kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2004-08-24
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2019-05-07
FNP	Urinal	General Hospital	Class 1	880.6730	1992-08-18
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-08-18
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2017-06-13
IWW	Shield, Vial	Radiology	Class 1	892.6500	2012-03-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2012-03-11
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2007-12-17

Official Correspondent

Elyssa Murray

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bracco Diagnostics Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2411512. Last updated year: 2026. Please use registration number 2411512 when referencing this establishment in official correspondence.