Novasight Hybrid™ PIM
The Novasight Hybrid Patient Interface Module connects the imaging catheter to the Novasight Hybrid intravascular imaging system. It provides controls that allow the physician to manage…
The Novasight Hybrid Patient Interface Module connects the imaging catheter to the Novasight Hybrid intravascular imaging system. It provides controls that allow the physician to manage image acquisition during coronary artery procedures.
The module forms part of a system combining ultrasound and optical coherence tomography imaging. The acquisition and display module receives the imaging information for display and review, while the patient interface module provides the catheter connection near the procedure.
Sterile Interface
The patient interface module is a motor drive unit used inside a single-use disposable sterile bag. It is compact enough to be moved and handled by the user. The system is indicated for coronary imaging in patients undergoing transluminal interventional procedures.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Jiangsu Tingsn Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 4 |
| Nanjing Shuangwei Biotechnology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Conavi Medical Inc, Canada |
|---|---|
| FDA product code | OBJ |
| Device type | Catheter, Ultrasound, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K172258 |
| Record published | 2022-10-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA-07-0001 | In distribution | |
| TA-07-0002 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 27 |
| Acist HDi® HD Ivus System | Acist Medical Systems, Inc. | 8 |
| Soundstar | Biosense Webster, Inc. | 6 |
| OptiCross | Boston Scientific Corporation | 4 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Acist HDi® System Console | Acist Medical Systems, Inc. | 4 |
| OptiCross™ 6 | Boston Scientific Corporation | 3 |
| 7 Fr PV-Catheter | CD Leycom | 3 |
| NES Reprocessed Visions PV.014P RX Digital Ivus Catheter | North East Scientific Inc | 3 |
| OptiCross™ 6 HD | Boston Scientific Corporation | 2 |
| Acist HDi® Bed Rail Mount | Acist Medical Systems, Inc. | 2 |
| 4 Fr PV Catheter | CD Leycom | 2 |
Showing 12 of 63. All products under Catheter, Ultrasound, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252945 | 2026-04-17 |
| K172258 | 2018-04-27 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Conavi Medical Inc | 510(k) number | 2025-03-12 | Class I | Process control | Due to manufacturing issues there is a potential for the catheter sheath to detach. | 685 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.