Acessa Table Top Field Generator
Acessa Table Top Field Generator (TTFG), connects to the Acessa ProVu Console. Includes TTFG Pad Set
Tracking, Soft Tissue, Intraoperative
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- ATL Technology DG,Ltd. Guangdong, contract manufacturer
What Is This Device?
For open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
How Is OEW Classified?
Tracking, Soft Tissue, Intraoperative is FDA product code OEW, Class 2, 21 CFR 882.4560.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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