The following data is part of a premarket notification filed by Qisda Corporation with the FDA for Innosight Diagnostic Ultrasound System.
| Device ID | K192254 |
| 510k Number | K192254 |
| Device Name: | InnoSight Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Qisda Corporation No.157, Shanying Rd, Shan-Ting Li, Gueishan Dist, Taoyuan, TW |
| Contact | Johnson Sheu |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-08-20 |
| Decision Date | 2019-09-18 |
| Summary: | summary |