The following data is part of a premarket notification filed by Sonic Incytes with the FDA for Liver Incytes, Model 1005.
| Device ID | K201597 |
| 510k Number | K201597 |
| Device Name: | Liver Incytes, Model 1005 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Sonic Incytes 560-828 West 10th Ave Vancouver, CA V5z 1m9 |
| Contact | George Aliphtiras |
| Correspondent | Rhona Shanker Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, MD 20878 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-12 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B995LI10050 | K201597 | 000 |