The following data is part of a premarket notification filed by Terarecon Inc., with the FDA for Intuition-t1 Mapping And T2/t2* Mapping.
| Device ID | K180916 |
| 510k Number | K180916 |
| Device Name: | INtuition-T1 Mapping And T2/T2* Mapping |
| Classification | System, Image Processing, Radiological |
| Applicant | TeraRecon Inc., 4000 East 3rd Avenue, Suite 200 Foster City, CA 94404 |
| Contact | Megha Jain |
| Correspondent | Megha Jain TeraRecon Inc., 4000 East 3rd Avenue, Suite 200 Foster City, CA 94404 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-09-24 |
| Summary: | summary |