Ablation systems
Dophi
by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
A hand-held device intended to be used to monitor tissue temperature during a surgical ablation procedure (e.g., cryosurgical, microwave, or radio-frequency ablation), typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the surgical ablation system control unit. This is a single-use device.
Dophi models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| M150E | β | Not stated | Available |
| SS-MWA-1526C | β | Not stated | Available |
| SS-MWA-1531C | β | Not stated | Available |
| SS-MWA-2026C | β | Not stated | Available |
| SS-MWA-2031C | β | Not stated | Available |
| SS-MWA-2526C | β | Not stated | Available |
| SS-MWA-2531C | β | Not stated | Available |
| SS-TP18G-20 | β | Not stated | Available |
FDA clearances
- 510(k) K183153 July 2019
Procedures that use ablation systems
Frequently asked questions
What is Dophi used for?
A hand-held device intended to be used to monitor tissue temperature during a surgical ablation procedure (e.g., cryosurgical, microwave, or radio-frequency ablation), typically to measure the temperature in tissue adjacent to the ablated zone to assess extent of ablation and to limit ablation to protect local tissues. It is in the form of a needle-like probe with a temperature sensor and proximal handle with a cable for connecting to the surgical ablation system control unit. This is a single-use device.
Who makes Dophi?
Dophi is made by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does Dophi come in?
The FDA device database does not list sizes for Dophi. Check the instructions for use or ask a Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. representative.
Is Dophi MRI safe?
The FDA device database entry for Dophi does not state its MRI safety status. Check the labeling before MRI.
Is Dophi FDA cleared?
Dophi is covered by FDA submission K183153.
How do I contact a Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. sales representative?
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.