The following data is part of a premarket notification filed by Terarecon Inc. with the FDA for Intuition-structural Heart Module.
| Device ID | K191585 |
| 510k Number | K191585 |
| Device Name: | INtuition-Structural Heart Module |
| Classification | System, Image Processing, Radiological |
| Applicant | TeraRecon Inc. 4000 East, 3rd Ave, Suite 200 Foster City, CA 94402 |
| Contact | Megha Jain |
| Correspondent | Megha Jain TeraRecon Inc. 4000 East, 3rd Ave, Suite 200 Foster City, CA 94402 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-07-12 |