ImagenSPECT - ImagenSPECT™ 3.0 is a Windows application which - CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.

Duns Number:626962596

Device Description: ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professio ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

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More Product Details

Catalog Number

-

Brand Name

ImagenSPECT

Version/Model Number

3.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

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FDA Premarket Submission

K152503,K201933

Product Code Details

Product Code

KPS

Product Code Name

System, Tomography, Computed, Emission

Device Record Status

Public Device Record Key

82ad6028-d6fb-4be8-a301-eee73661a42d

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5