Makoto Intravascular Imaging System™

Basic Information

• Brand Name: Makoto Intravascular Imaging System™
• Primary DI: 00857595006432
• Version / Model: TVC-MC10
• Catalog Number: TVC-MC10
• Company Name: INFRAREDX, INC.
• Labeler DUNS: 124065421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-11
• Public Version: 4
• Public Version Date: 2022-11-10
• Public Version Status: Update
• Public Device Record Key: a480f115-d5e1-4c74-bd51-dff815e4e71a

Device Description

The Makoto Intravascular Imaging System™ (TVC-MC10) is a dual-modality intravascular imaging system that enables structural and chemical assessment of coronary arteries and plaques by using integrated Extended Bandwidth IVUS imaging and NIRS (near infrared spectroscopy) technologies to identify lipid-core plaques (LCP) of interest. The system utilizes proprietary NIRS analysis and 50 MHz 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 Dualpro™ IVUS+NIRS Imaging Catheter Kit (TVC-C195-42). Indications for Use: 1. The Makoto Intravascular 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	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	00857595006432	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -12 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity