Identifiers
- 510(k) Number
- K143024 FDA 510(k)
- FDA Product Code
- OEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
CAS-One Liver is a tracking, soft tissue, intraoperative device used for image-guided interventions. It integrates advanced 3D model-based stereotactic image guidance with intra-operative ultrasound imaging to enhance precision in liver surgery.
The device is supplied as a system for use in intraoperative settings. It has received FDA 510(k) clearance under K143024 and is classified as a Class II device with product code OEW. It is intended for use in neurology-related applications as indicated by the advisory committee description.
Frequently asked questions
What is the CAS-One Liver device used for?
The CAS-One Liver is a tracking, soft tissue, intraoperative device used for image-guided interventions. It integrates advanced 3D model-based stereotactic image guidance with intra-operative ultrasound imaging to enhance precision in liver surgery, as stated in the device description.
How is the CAS-One Liver device supplied and is it reusable?
The device is supplied as a system for use in intraoperative settings. The data does not specify whether it is single-use or reusable, so no determination about reusability can be made from the provided information.
What regulatory clearance does the CAS-One Liver have and what is its classification?
The CAS-One Liver has received FDA 510(k) clearance under K143024 and is classified as a Class II device with product code OEW, as explicitly stated in the device data.
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: Quality Ablation with CAS-One - CASCINATION, CAS-One Liver - CAScination - PDF Catalogs - MedicalExpo, PDF CAS-One IR - memed.cz, CAS-One Liver (K143024) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143024 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CAScination AG
Sources (1)
- FDA 510(k) K143024 24 fields · synced Sep 28, 2026