Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
BRILLIANT SYSTEM SOLUTIONS PTE LTD
Class C medical device
Nanjing ECO Microwave system Co ltd
General & Plastic Surgery
For ablation of soft tissue during open, laparoscopic, or percutaneous procedures. It is not intended for cardiac use. Indications: -- Liver tumor: Primary treatment/curative treatment only if: 1 nodule<5 cm or 3 nodules<3 cm (including BCLC 0 and A-stage HCC); and no portal vein cancerous thrombus; and no extra hepatic spread. -- Lung tumor: Pulmonary metastatic disease only if:≤3 unilateral lesions (bilateral ≤5);multiple metastases ≤3 cm, or unilateral single metastasis ≤ 5 cm, without other metastatic disease; and other available treatments have failed or deemed unsuitable. -- Kidney tumor: Stage T1a renal cell carcinoma (RCC), with tumor size ≤4 cm and no evidence of spread beyond the kidney, only if: patients cannot undergo a partial nephrectomy; or have impaired kidney function; or have high surgical risk. -- Thyroid nodule: Benign thyroid tumors only if other available treatments have failed or deemed unsuitable. -- Varicose vein: Great Saphenous Vein.
Device System Info:[Sterile Medical Device], ECO Microwave Therapeutic System is designed to be used by physicians who are trained in the use and application of Image-guided ablation procedures, Intraoperative ultrasound and/or CT guided needle placement.; Models: Microwave Therapeutic System - ECO-100E2, Disposable Microwave Therapeutic Antenna - ECO-100CL5, Disposable Microwave Therapeutic Antenna - ECO-100CL22, Disposable Microwave Therapeutic Antenna - ECO-100CL8, Disposable Microwave Therapeutic Antenna - ECO-100CL5C, Disposable Microwave Therapeutic Antenna - ECO-100CL10, Disposable Microwave Therapeutic Antenna - ECO-100CL22C, Disposable Microwave Therapeutic Antenna - ECO-100CL11, Disposable Microwave Therapeutic Antenna - ECO-100CL8C, Disposable Microwave Therapeutic Antenna - ECO-100CL10C, Disposable Microwave Therapeutic Antenna - ECO-100CL11C, Disposable Microwave Therapeutic Antenna - ECO-100AI1, Disposable Microwave Therapeutic Antenna - ECO-100AI20C, Disposable Microwave Therapeutic Antenna - ECO-100AI3, Disposable Microwave Therapeutic Antenna - ECO-100AI5, Disposable Microwave Therapeutic Antenna - ECO-100AI22, Disposable Microwave Therapeutic Antenna - ECO-100AI5C, Disposable Microwave Therapeutic Antenna - ECO-100AI23C, Disposable Microwave Therapeutic Antenna - ECO-100AL23C, Disposable Microwave Therapeutic Antenna - ECO-100AI13C, Disposable Microwave Therapeutic Antenna - ECO-100AL13C, Disposable Microwave Therapeutic Antenna - ECO-100AI8, Disposable Microwave Therapeutic Antenna - ECO-100AL8, Disposable Microwave Therapeutic Antenna - ECO-100AI10, Disposable Microwave Therapeutic Antenna - ECO-100AL10, Disposable Microwave Therapeutic Antenna - ECO-100AI8C, Disposable Microwave Therapeutic Antenna - ECO-100AI10C, Disposable Microwave Therapeutic Antenna - ECO-100AI30
2021-04-16