The following data is part of a premarket notification filed by Qisda Corporation with the FDA for Innosight Diagnostic Ultrasound System.
| Device ID | K172056 |
| 510k Number | K172056 |
| Device Name: | InnoSight Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Qisda Corporation No.157, Shanying Rd., Gueishan Dist, Taoyuan City, TW 333 |
| Contact | Johnson Sheu |
| Correspondent | Bob Leiker Leiker Regulatory & Quality Consulting 4157 North Del Ray Circle Clovis, CA 93619 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-06 |
| Decision Date | 2017-12-13 |
| Summary: | summary |