The following data is part of a premarket notification filed by Jointvue Llc with the FDA for 3d Echo V1.1.
| Device ID | K211656 |
| 510k Number | K211656 |
| Device Name: | 3D Echo V1.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | JointVue LLC 2450 E.J. Chapman Drive, Suite 104A Knoxville, TN 37996 |
| Contact | Maja Ward |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-05-28 |
| Decision Date | 2021-06-25 |