SpectraWAVE Imaging Catheter

FDA registration

SPECTRAWAVE, INC.·1 product·🇺🇸 United States

TVC Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006401·TVC Imaging System™ The TVC Imaging System™ (TV...

TVC Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006418·TVC Imaging System™ The TVC Imaging System™ (TV...

TVC Integrated Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006623·TThe TVC Integrated Imaging System™ (TVC-MC9i) ...

TVC Insight™

FDA UDI

INFRAREDX, INC.·00857595006210·Insight Hydrophilic Catheter™ Kit The TVC Insi...

Infraredx Clarispro™ HD-IVUS Imaging Catheter Kit

FDA UDI

INFRAREDX, INC.·00857595006180·The Infraredx Clarispro™ HD-IVUS Imaging Cathet...

TVC Insight XB™

FDA UDI

INFRAREDX, INC.·00857595006227·Insight XB™ Catheter Kit The TVC Insight XB™ Ex...

Dualpro™ IVUS+NIRS Imaging Catheter Kit

FDA UDI

INFRAREDX, INC.·00857595006234·The Dualpro™ IVUS+NIRS Imaging Catheter Kit (TV...

TVC Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006425·TVC Imaging System™ The TVC Imaging System™ (TV...

Makoto Intravascular Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006432·The Makoto Intravascular Imaging System™ (TVC-M...

TVC Controller Sterile Barrier

FDA UDI

INFRAREDX, INC.·00857595006005·Individual Sterile Barrier for TVC-MC8 or TVC-M...

Makoto Integrated Intravascular Imaging System™

FDA UDI

INFRAREDX, INC.·00857595006166·The Makoto Integrated Intravascular Imaging Sys...

InfraredX

FDA registration

MICROTEK DOMINICANA, S.A.·3 products·🇩🇴 Dominican Republic

Imaging System

FDA registration

Sterigenics U.S., LLC·3 products·🇺🇸 United States

Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42)

FDA registration

INFRAREDX, INC.·3 products·🇺🇸 United States

TVC IMAGING SYSTEM, TVC INSIGHT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

TVC IMAGING SYSTEM MODEL NIRS-MC7-70

FDA 510(k)

FDA Class 2 ·Cardiovascular

Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70

FDA 510(k)

FDA Class 2 ·Cardiovascular