TeraRecon, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1070-2015 | Class II | Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Commu | January 21, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250288 | TeraRecon Cardiovascular.Calcification.CT | October 23, 2025 |
| K243158 | TeraRecon Aorta.CT (1.1.0) | January 23, 2025 |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | November 5, 2024 |
| K220349 | TeraRecon Neuro | August 12, 2022 |
| K200750 | Neuro.Al Algorithm | November 6, 2020 |
| K191585 | iNtuition-Structural Heart Module | July 12, 2019 |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | September 24, 2018 |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | December 24, 2013 |
| K121916 | INTUITION | April 2, 2013 |
| K061214 | AQUARIUSAPS SERVER | May 15, 2006 |
| K012086 | AQUARIUSNET SERVER | September 13, 2001 |
| K011142 | AQUARIUS WORKSTATION | May 8, 2001 |
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | May 26, 2000 |
| K974307 | RTR-2000/RTR-4000 | February 13, 1998 |