Terarecon,Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Terarecon,Inc.” (first 1998, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 162 days. Since 2017 the median was 180 days, against 130 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 246 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 168 |
| 2019 | 1 | 28 |
| 2020 | 1 | 228 |
| 2021 | 0 | — |
| 2022 | 1 | 186 |
| 2023 | 0 | — |
| 2024 | 1 | 180 |
| 2025 | 2 | 190 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Terarecon,Inc. took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 130 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 9 | 9 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 | 1 |
Review panels
- Radiology (14)
Most recent Terarecon,Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250288 | TeraRecon Cardiovascular.Calcification.CT | QIH | 2025-10-23 | 265 |
| K243158 | TeraRecon Aorta.CT (1.1.0) | QIH | 2025-01-23 | 115 |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | QIH | 2024-11-05 | 180 |
| K220349 | TeraRecon Neuro | LLZ | 2022-08-12 | 186 |
| K200750 | Neuro.Al Algorithm | LLZ | 2020-11-06 | 228 |
| K191585 | iNtuition-Structural Heart Module | LLZ | 2019-07-12 | 28 |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | LLZ | 2018-09-24 | 168 |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | LLZ | 2013-12-24 | 218 |
| K121916 | INTUITION | LLZ | 2013-04-02 | 274 |
| K061214 | AQUARIUSAPS SERVER | LLZ | 2006-05-15 | 13 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2015-01-21.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Terarecon,Inc.?
FDA lists 14 510(k) clearances under the applicant name “Terarecon,Inc.” (first 1998, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Terarecon,Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terarecon,Inc. is 162 days. Since 2017: 180 days, versus 130 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Terarecon,Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 9); QIH (Automated Radiological Image Processing Software, 3); JAK (System, X-Ray, Tomography, Computed, 1).
Next steps
- See all 14 Terarecon,Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Terarecon,Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.