FDA.reportPublic FDA data

ImagenSPECT

Primary DI
00862611000301
Brand
ImagenSPECT
Company
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
Model
2.0
Device description
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
Published
2016-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPSSystem, Tomography, Computed, Emission
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152503000ImagenSPECTCardiovascular Imaging Technologies2016-01-25KPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862611000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862611000301008626110003018626110003010862611000301

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a single photon emission computed tomography (SPECT) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
816-531-2842scourter@cvit.com

Regulatory Flags#

DUNS number
626962596
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862611000363ImagenQ3.02025-10-31
00862611000356ImagenQ2.12025-01-09
00862611000349ImagenSPECT3.02020-11-02
00862611000318ImagenPRO2.22018-01-29
00862611000325ImagenQV2.02018-02-21
00862611000332ImagenUniversal2.02018-01-31

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Primary DI, Brand, Company table
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08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
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08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
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