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Sign in to claim this brandCorindus, Inc.
US
Last updated May 27, 2026
What Corindus, Inc. makes
Corindus manufactures robotic and imaging systems for cardiac interventional procedures, including robotic drive units, extended-reach arms, and control consoles designed for precision catheter navigation. Their portfolio also includes colour image display units and portable radiation shielding panels to support fluoroscopy-based interventions. The company produces modular components like cassettes, drapes, and gear systems tailored for interventional cockpits, as well as standalone imaging workstations for procedural guidance.
The company’s devices are classified under FDA regulations as Class I and Class II, with authorisations granted through the 510(k) and UDI pathways. These products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. Corindus operates as a US-based manufacturer, adhering to domestic regulatory requirements for interventional and imaging technologies.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Corindus, Inc. manufacture?
Corindus, Inc. specializes in robotic and imaging systems primarily for cardiac interventional procedures. Their portfolio includes robotic drive units, extended-reach arms, and control consoles designed to assist in precise catheter navigation. Additionally, they produce colour image display units and portable radiation shielding panels to support fluoroscopy-based interventions. The company also offers modular components like cassettes, drapes, and gear systems for interventional setups, as well as standalone imaging workstations for procedural guidance.
Where is Corindus, Inc. based, and how does this affect its regulatory compliance?
Corindus, Inc. is based in the United States, which means its devices must comply with FDA regulations. Since the company operates domestically, its products are subject to US-specific authorisation pathways, such as the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This ensures alignment with US medical device standards and regulatory requirements.
Which regulatory registries or databases list Corindus, Inc.’s devices?
Corindus, Inc.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure transparency and compliance with US medical device regulations, allowing healthcare providers and regulators to verify the authorised status of individual products.
How are Corindus, Inc.’s devices classified under FDA regulations?
Corindus, Inc.’s devices are classified under FDA regulations as either Class I or Class II. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification determines the regulatory pathway for authorisation, with Corindus devices primarily authorised through the 510(k) process, which compares them to predicate devices already on the market.
What kinds of imaging and robotic systems does Corindus, Inc. develop for cardiac procedures?
Corindus, Inc. develops a range of robotic and imaging systems tailored for cardiac interventional procedures, including robotic drive units and extended-reach arms that enhance catheter navigation precision. Their imaging solutions include colour display units and portable radiation shielding panels to support fluoroscopy, while modular components like cassettes and drapes integrate into interventional cockpits. These systems are designed to improve procedural guidance and safety in complex cardiac interventions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- siemens-healthineers.com
- —
- —
- [email protected]
- Phone
- +1-800-888-7436
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 781746586
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Powervision Imaging System | 104 | FDA UDI | Class I | Active |
| CorPath 200 Robotic Drive | 160-00050 | FDA UDI | Class II | Unknown |
| CorPath GRX Control Console | 301 | FDA UDI | Class II | Active |
| CorPath Imaging System | 105 | FDA UDI | Class I | Active |
| CorPath GRX Extended Reach Arm | 302 | FDA UDI | Class II | Active |
| CorPath Imaging System | 106 | FDA UDI | Class I | Active |
| CorPath 200 Cassette | 160-00173-NC | FDA UDI | Class II | Unknown |
| CorPath 200 Articulated Arm | 160-00807 | FDA UDI | Class II | Unknown |
| CorPath Interventional Cockpit | 101 | FDA UDI | Class I | Active |
| CorPath 200 Control Console Drape | 160-00981 | FDA UDI | Class II | Unknown |
| CorPath GRX Robotic Drive | 303 | FDA UDI | Class II | Active |
| Powervision Imaging System | 103 | FDA UDI | Class I | Active |
| CorPath 200 Robotic Drive Drape | 160-00828 | FDA UDI | Class II | Unknown |
| CorPath GRX Cassette Duo | 319 | FDA UDI | Class II | Active |
| CorPath 200 Control Console | 160-00043 | FDA UDI | Class II | Unknown |
| CorPath GRX Drive Gear | 307 | FDA UDI | Class II | Active |
| CorPath 200 POGO Pin Caps | 160-00876 | FDA UDI | Class II | Unknown |
| CorPath GRX Extended Reach Arm | 312 | FDA UDI | Class II | Active |
| Powervision Imaging System | 102 | FDA UDI | Class I | Unknown |
| CorPath GRX Drape, Control Console | 311 | FDA UDI | Class II | Active |
| CorPath GRX Cassette | 305 | FDA UDI | Class II | Active |
| CorPath GRX Drape, Robotic Drive and Arm | 309 | FDA UDI | Class II | Active |
| CorPath 200 Joystick Covers | 160-00692 | FDA UDI | Class II | Unknown |
| Corpath 200 System | K120834 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K221464 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K173288 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K180517 | FDA 510(k) | Class II | Active |
| CorPath 200 System | K152999 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K202275 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K160121 | FDA 510(k) | Class II | Active |
| CorPath 200 System | K150892 | FDA 510(k) | Class II | Active |
| CorPath GRX System | K173806 | FDA 510(k) | Class II | Active |
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