TVC Imaging System™

Basic Information

Brand Name: TVC Imaging System™
Primary DI: 00857595006401
Version / Model: TVC-MC8
Catalog Number: TVC-MC8
Company Name: INFRAREDX, INC.
Labeler DUNS: 124065421
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-15
Public Version: 4
Public Version Date: 2018-11-20
Public Version Status: Update
Public Device Record Key: 18e89d24-47e6-433d-bcaf-5ab28849ea35

Device Description

TVC Imaging System™ The TVC Imaging System™ (TVC-MC8) 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 enhanced IVUS imaging technology to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 40MHz rotational IVUS imaging from a single catheter. The system is compatible with the TVC Insight™ Catheter Kit (TVC-C195-20) and TVC Insight Hydrophilic Catheter Kit (TVC-C195-22). The system can be configured for Extended Bandwidth™ making the system compatible with the TVC Insight XB™ Extended Bandwidth NIRS-IVUS Catheter Kit (TVC-C195-32) that provides NIRS and 50MHz rotational IVUS imaging. Non-RoHs 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.

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	870.1200	2
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40763	Cardiovascular ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static or real-time cardiac specific imaging applications used to diagnose anatomical defects of the heart, determine blood flow characteristics and functional/anatomical problems associated with myocardial infarction. It is used to generate ultrasound pulses, direct them to a target area, detect the echoes, and process the resulting information to produce and display static or dynamic two or three-dimensional (3-D) images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857595006401	GS1

Customer Contacts

Phone: 888-680-7339
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133897	000

Device Sizes

Type	Value	Unit
Width	26	Inch
Height	62	Inch
Depth	30	Inch
Weight	189	Pound

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -12 – 50 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 20 – 80 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 15 – 32 Degrees Celsius