Identifiers
- 510(k) Number
- K172258 FDA 510(k)
- FDA Product Code
- OBJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Novasight Hybrid System is a catheter-based intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging system. It is designed for cardiovascular imaging and provides combined IVUS and OCT capabilities through a single console.
The system is supplied as a reusable console with single-use IVUS and OCT catheters. It is intended for use in cardiovascular procedures within a clinical setting, such as a cath lab, and has received FDA 510(k) clearance under K172258. The device is classified as a Class II medical device with product code OBJ and regulation number 870.1200.
Frequently asked questions
What is the Novasight Hybrid System used for?
The Novasight Hybrid System is designed for cardiovascular imaging and provides combined intravascular ultrasound (IVUS) and optical coherence tomography (OCT) capabilities through a single console, intended for use in clinical settings such as a cath lab.
How is the Novasight Hybrid System supplied and is it reusable?
The system is supplied as a reusable console with single-use IVUS and OCT catheters, meaning the console can be reused after proper cleaning while the catheters are discarded after each procedure.
What regulatory pathway was used for the Novasight Hybrid System?
The Novasight Hybrid System received FDA 510(k) clearance under K172258, indicating it was found substantially equivalent to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - Novasight Hybrid System, Product - Novasight Hybrid System - conavi.com, Conavi Medical submits Novasight Hybrid IVUS/OCT System to FDA for 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172258 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conavi Medical Inc
- FDA Applicant
- Conavi Medical, Inc.
Sources (1)
- FDA 510(k) K172258 24 fields · synced Sep 25, 2026