ClearRead CT Console
20 catalogue numbers from 5.5.0, listed by Riverain Technologies, United States, under Lung Computed Tomography System, Computer-Aided Detection. 1 manufacturer in China is registered for this product code.
1manufacturer
20catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Record
| Listed by | Riverain Technologies, United States |
|---|---|
| FDA product code | OEB |
| Device type | Lung Computed Tomography System, Computer-Aided Detection |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K161201 |
| Record published | 2019-04-11 |
| Record revised | 2023-10-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2019-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5.5.0 | In distribution | |
| 5.0.0 | In distribution | |
| 5.2.0 | In distribution | |
| 1.0.2 | In distribution | |
| 1.2.0 | In distribution | |
| 5.8.0 | In distribution | |
| 5.8.1 | In distribution | |
| 5.8.5 | In distribution | |
| 5.8.2 | In distribution | |
| 5.11 | In distribution | |
| 5.7.0 | In distribution | |
| 5.6.1 | In distribution | |
| 5.6.0 | In distribution | |
| 5.6.3 | In distribution | |
| 5.8.4 | In distribution | |
| 1.1.1 | In distribution | |
| 5.8.3 | In distribution | |
| 5.6.2 | In distribution | |
| 5.11.1 | In distribution | |
| 1.0.0.26 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ClearRead CT Server | Riverain Technologies | 16 |
| ClearRead CT Docker | Riverain Technologies | 14 |
| ClearRead CT | Riverain Technologies | 11 |
| ClearRead CT Platform Docker | Riverain Technologies | 7 |
| Veolity | Mevis Medical Solutions AG | 2 |
| Veolity LungCAD | Mevis Medical Solutions AG | 2 |
| Visia LungCAD | Mevis Medical Solutions AG | 2 |
| DynaCAD Lung Server | Mevis Medical Solutions AG | 2 |
| InferRead Lung Ct.ai 2.1.2.1 | Infervision US Inc | 1 |
| InferRead Lung Ct.ai | Infervision Medical Technology Co., Ltd. | 1 |
| Aview Lung Nodule CAD | Coreline Soft Co., Ltd. | 1 |
| DynaCAD Lung | Mevis Medical Solutions AG | 1 |
Showing 12 of 13. All products under Lung Computed Tomography System, Computer-Aided Detection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221612 | 2022-12-05 |
| K161201 | 2016-09-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.