EndoSound® Vision System (EVS) Software
The EndoSound Vision System software processes ultrasound data from the EVSScanner module and displays the resulting image on a computer monitor. It supplies the user interface for the EVS…
The EndoSound Vision System software processes ultrasound data from the EVSScanner module and displays the resulting image on a computer monitor. It supplies the user interface for the EVS add-on ultrasound system used with a compatible upper gastrointestinal endoscope.
The EVSViewer software recognises the system’s transducer through an electronic chip in the ultrasound transducer module. It processes the incoming ultrasound data while the scanner and attached transducer acquire images, supporting the display used during endoscopic ultrasound procedures.
Listed Item
The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC’s monitor.
Field of View and Use Counter
The software fixes the ultrasound field of view at the full 150 degrees. A startup dialogue debits the attached transducer’s preprogrammed use counter and locks the probe out when its permitted uses are exhausted.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Endosound Inc, United States |
|---|---|
| FDA product code | ODG |
| Device type | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K232518 |
| Record published | 2024-01-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Storage | Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 75 to 106 KiloPascal; Handling environment temperature -10 to 60 °C; Storage environment atmospheric pressure 75 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 22 |
| Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA) | Micro-Tech (Nanjing) Co., Ltd. | 12 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA) | Micro-Tech (Nanjing) Co., Ltd. | 6 |
| Pentax Medical | Hoya Corporation | 6 |
| Water-resistant Cap | Olympus Medical Systems Corp. | 6 |
| Expect | Boston Scientific Corporation | 4 |
| Ultrasonic Probe | Olympus Medical Systems Corp. | 4 |
| BALLOON3 | Olympus Medical Systems Corp. | 3 |
| Acquire | Boston Scientific Corporation | 3 |
| Evis-EUS Image Cable | Olympus Medical Systems Corp. | 3 |
| Expect Slimline SL | Boston Scientific Corporation | 3 |
| Evis Exera II Ultrasound Gastrovideoscope | Olympus Medical Systems Corp. | 2 |
Showing 12 of 52. All products under Endoscopic Ultrasound System, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232518 | 2023-12-27 |
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.