Riverain Technologies
Miamisburg, OH, US
RIVERAIN TECHNOLOGIES appears in FDA device records in Miamisburg, OH. FDA records list 8 510(k) clearances between and , 9 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Riverain Technologies carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Riverain Medical Group,Llc510(k), PMA, recall
510(k) clearance history
FDA records hold 8 510(k) clearances for Riverain Technologies between 2007 and 2024. The busiest year on record is 2022, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242188 | ClearRead CT CAC | JAK | Substantially Equivalent | |
| K221612 | ClearRead CT | OEB | Substantially Equivalent | |
| K213566 | ClearRead Xray Pneumothorax | QFM | Substantially Equivalent | |
| K161201 | ClearRead CT | OEB | Substantially Equivalent | |
| K123526 | CLEARREAD +CONFIRM | LLZ | Substantially Equivalent | |
| K111776 | DELTAVIEW MODEL 2.1 | LLZ | Substantially Equivalent | |
| K092363 | SOFTVIEW, MODEL 2.01 | LLZ | Substantially Equivalent | |
| K071492 | FIRSTVIEW | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005156333 | 3005156333 | RIVERAIN TECHNOLOGIES | 3130 SOUTH TECH BLVD., MIAMISBURG, OH 45342 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1174-06 | RapidScreen RS-Digital, Medical Image Analyzer. | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity. | Terminated | ||
| Z-1173-06 | RapidScreen RS-2000D, Medical Image Analyzer. | The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain