TVC Imaging System, TVC Catheter
K-Number: K163345 · 2017-06-21
ApplicantInfraredx, Inc.
Decision Date2017-06-21
Product CodeOGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TVC Imaging System, TVC Catheter is a medical device manufactured by Infraredx, Inc.. It received FDA 510(k) clearance on 2017-06-21 under approval number K163345. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TVC Imaging System, TVC Catheter?
TVC Imaging System, TVC Catheter is a medical device that received FDA 510(k) clearance on 2017-06-21. It is manufactured by Infraredx, Inc.. The 510(k) number is K163345.
When was TVC Imaging System, TVC Catheter approved by the FDA?
TVC Imaging System, TVC Catheter received FDA 510(k) clearance on 2017-06-21, under approval number K163345.
What company makes TVC Imaging System, TVC Catheter?
TVC Imaging System, TVC Catheter is manufactured by Infraredx, Inc..
What is the FDA product code for TVC Imaging System, TVC Catheter?
The FDA product code for TVC Imaging System, TVC Catheter is OGZ.
Related Clinical Trials
NCT07475091
Standardizing Swallow Pressure Measurements
NOT_YET_RECRUITING
NCT01143454
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
RECRUITING
NCT03331380
Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System
RECRUITING
NCT02193425
Reliability of the Human Brain Connectome
COMPLETED
NCT06510556
Feasibility Study of the FARAFLEX Mapping and PFA System
RECRUITING
NCT04981223
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging
COMPLETED
Related PubMed Literature
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 40775988
B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation.
Studies in health technology and informatics (2025)
PMID: 40346298
An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients.
NPJ digital medicine (2025)
Other Devices by Infraredx, Inc.
K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42
K241576Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )
Related Devices (Code: OGZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.