Riverain Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Riverain Technologies, Inc.” (first 2012, latest 2024), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 131 days. Since 2017 the median was 131 days, against 129 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 | 1 | 42 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 134 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 153 |
| 2023 | 0 | — |
| 2024 | 1 | 131 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Riverain Technologies, Inc. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 129 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | 2 | 2 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 | 1 |
Review panels
- Radiology (5)
Most recent Riverain Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242188 | ClearRead CT CAC | JAK | 2024-12-03 | 131 |
| K221612 | ClearRead CT | OEB | 2022-12-05 | 185 |
| K213566 | ClearRead Xray Pneumothorax | QFM | 2022-03-10 | 121 |
| K161201 | ClearRead CT | OEB | 2016-09-09 | 134 |
| K123526 | CLEARREAD +CONFIRM | LLZ | 2012-12-27 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Riverain Technologies, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Riverain Medical Group,Llc (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Riverain Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Riverain Technologies, Inc.” (first 2012, latest 2024), 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 Riverain Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Riverain Technologies, Inc. is 131 days. Since 2017: 131 days, versus 129 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Riverain Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OEB (Lung Computed Tomography System, Computer-Aided Detection, 2); JAK (System, X-Ray, Tomography, Computed, 1); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Riverain Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OEB, Riverain Technologies, 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.