IntelliBlate Microwave Ablation System Console
The IntelliBlate console generates microwave energy for soft tissue ablation when used with the compatible IntelliBlate Ximitry probe assembly. The tabletop console is the energy and…
The IntelliBlate console generates microwave energy for soft tissue ablation when used with the compatible IntelliBlate Ximitry probe assembly. The tabletop console is the energy and control unit of the system, which is not intended for cardiac procedures.
Its 2.45 GHz microwave generator is controlled through a graphical interface that monitors and controls therapy delivery. An integrated peristaltic pump circulates coolant through the connected probe assembly’s closed fluid circuit.
Listed Item
IntelliBlate microwave ablation system console only for tabletop configuration
System Components
The console requires the appropriate probe assembly, coolant tubing cassette and fluid mount for the treatment arrangement. The sterile, single-use probe assembly is a separate accessory that delivers energy at the treatment site.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Betters(Suzhou) Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Nanjing Devin Medical Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| ECO Medical Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| Mima-PRO (NAN Tong) Scientific Inc. | Nantong | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Varian Medical Systems, Inc, United States |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K240480 |
| Record published | 2024-08-09 |
| Record revised | 2025-10-06 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IB-CON | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microwave Ablation Antennas | Canyon Medical Inc. | 66 |
| Neuwave | Neuwave Medical, Inc. | 25 |
| ECO Disposable microwave therapeutic antenna | ECO Medical Technology (Nanjing) Co., Ltd. | 21 |
| Hygea | Hygea Medical Technology Co., Ltd. | 18 |
| Avecure | MedWaves, Inc | 17 |
| Certus® 140 | Neuwave Medical, Inc. | 17 |
| Emprint | Covidien LP | 14 |
| Betters (Suzhou)Medical Co., Ltd. | Betters(Suzhou) Medical Co., Ltd. | 11 |
| Emprint SX | Covidien LP | 11 |
| Mima-Pro | Mima-PRO (NAN Tong) Scientific Inc. | 10 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 9 |
| Evident | Covidien LP | 8 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240480 | 2024-07-19 |
| K240784 | 2024-05-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.