Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Terarecon,Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
265 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | 2025-10-23 | 265 | 0 |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Terarecon,Inc. | 2025-01-23 | 115 | 0 |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Terarecon,Inc. | 2024-11-05 | 180 | 0 |
| K220349 | TeraRecon Neuro | Terarecon,Inc. | 2022-08-12 | 186 | 0 |
| K200750 | Neuro.Al Algorithm | Terarecon,Inc. | 2020-11-06 | 228 | 0 |
| K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019-07-12 | 28 | 0 |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Terarecon,Inc. | 2018-09-24 | 168 | 0 |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | Terarecon,Inc. | 2013-12-24 | 218 | 0 |
| K121916 | INTUITION | Terarecon,Inc. | 2013-04-02 | 274 | 1 |
| K061214 | AQUARIUSAPS SERVER | Terarecon,Inc. | 2006-05-15 | 13 | 0 |
| K012086 | AQUARIUSNET SERVER | Terarecon,Inc. | 2001-09-13 | 72 | 0 |
| K011142 | AQUARIUS WORKSTATION | Terarecon,Inc. | 2001-05-08 | 25 | 0 |
| K994329 | IIVS INTEGRATED IMAGE VIEWING STATION | Terarecon,Inc. | 2000-05-26 | 156 | 0 |
| K974307 | RTR-2000/RTR-4000 | Terarecon,Inc. | 1998-02-13 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda