The following data is part of a premarket notification filed by Hepatiq Llc with the FDA for Hepatiq 1.1.
| Device ID | K161188 |
| 510k Number | K161188 |
| Device Name: | HEPATIQ 1.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | HEPATIQ LLC 1150 Main Street, Suite E Irvine, CA 92614 |
| Contact | Dipu Ghosh |
| Correspondent | Dipu Ghosh HEPATIQ LLC 1150 Main Street, Suite E Irvine, CA 92614 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-06-09 |