Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004504920

FEI Number

3004504920

Entity Name

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC

City/State/Country

KANSAS CITY, MO, US

Establishment Address

4320 Wornall Rd Ste 114, KANSAS CITY, MO 64111, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC (Owner Number: 9059156)

Owner / Operator Contact Address

4320 WORNALL RD STE 114, --, Kansas City, MO 64111, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080770

PMA Number

N/A

All Registered Proprietary Names

ImagenSPECT ImagenUniversal ImagenSPECT 3 ImagenQ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2016-10-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2016-10-17
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2018-01-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-01-29
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-10-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-10-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-12-12

Official Correspondent

JAMES CASE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC

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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

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.

Similar Registrations

Registration Number	Establishment Name	Location
3032577207	POSITRIGO AG	Zurich, CH
3009136051	CEDARS SINAI MEDICAL CENTER	Los Angeles, CA, US
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3011950073	United Imaging Healthcare North America, Inc	Houston, TX, US
3008962177	GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.	Valencia, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004504920. Last updated year: 2026. Please use registration number 3004504920 when referencing this establishment in official correspondence.