The following data is part of a premarket notification filed by Mobilsonic, Inc. with the FDA for Vue 100 Ultrasound Imaging System.
| Device ID | K040652 |
| 510k Number | K040652 |
| Device Name: | VUE 100 ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MOBILSONIC, INC. 560 PARROTT STREET San Jose, CA 95112 |
| Contact | Bao Le |
| Correspondent | Bao Le MOBILSONIC, INC. 560 PARROTT STREET San Jose, CA 95112 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-11 |
| Decision Date | 2004-05-17 |
| Summary: | summary |