The following data is part of a premarket notification filed by Signostics Limited with the FDA for Speqrt.
| Device ID | K152250 |
| 510k Number | K152250 |
| Device Name: | SpeqRT |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Signostics Limited 1284 South Road Clovelly Park, AU 5042 |
| Contact | Stewart Bartlett |
| Correspondent | Mark Job 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 | 2015-08-10 |
| Decision Date | 2015-09-03 |
| Summary: | summary |