TVC Imaging System™ - TVC Imaging System™The TVC Imaging System™ - INFRAREDX, INC.

Duns Number:124065421

Device Description: TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imag TVC Imaging System™The TVC Imaging System™ (TVC-MC9) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated NIRS (near infrared spectroscopy) and Extended Bandwidth™ IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50MHz Extended Bandwidth rotational IVUS imaging from a single catheter. The system features a touch screen control interface and a workflow that fits the complex catheterization laboratory environment. The system is compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32).Indications for Use:1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. a. The System is intended for the detection of lipid-core-containing plaques of interest. b. The System is intended for the assessment of coronary artery lipid core burden. 2. The System is intended for ultrasound examination of coronary intravascular pathology. a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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More Product Details

Catalog Number

TVC-MC9

Brand Name

TVC Imaging System™

Version/Model Number

TVC-MC9

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141682

Product Code Details

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

449ba686-dcf9-4674-84cb-d047f40d534d

Public Version Date

November 20, 2018

Public Version Number

4

DI Record Publish Date

January 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INFRAREDX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13