ClearRead CT
by Riverain Technologies, Inc.
510(k) K161201
ClearRead CT is a medical device (FDA Class II; FDA product code OEB, Lung Computed Tomography System, Computer-Aided Detection) made by Riverain Technologies, Inc., cleared under FDA 510(k) K161201 on 9 Sep 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161201 | Date9 Sep 2016 | StatusActive |
Official records
- FDA 510(k) database K161201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OEB
- FDA applicant
- Riverain Technologies, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161201
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ClearRead CT Console 5.11 | 5.11 | M722CC25211V252110 | — | On the market |
| ClearRead CT Console 5.11.1 | 5.11.1 | M722CC26103V260970 | — | On the market |
| ClearRead CT Docker 5.11 | 5.11 | M722CD25211V252110 | — | On the market |
| ClearRead CT Docker 5.11.1 | 5.11.1 | M722CD26103V260970 | — | On the market |
| ClearRead CT Docker 5.11.2 | 5.11.2 | M722CD26127V260970 | — | On the market |
| ClearRead CT Docker for Partner 5.11.2.36 | 5.11.2.36 | M722CD26161V26097010 | — | On the market |
| ClearRead CT Docker for Partner 5.11.3.49 | 5.11.3.49 | M722CD26177V26097010 | — | On the market |
| ClearRead CT Platform Docker 5.11 | 5.11 | M722CP25215V252150 | — | On the market |
| ClearRead CT Platform Docker 5.11.1 | 5.11.1 | M722CP26104V261040 | — | On the market |
| ClearRead CT Platform Docker 5.11.3 | 5.11.3 | M722CP26183V261830 | — | On the market |
| ClearRead CT Server 5.11 | 5.11 | M722C25211V252110 | — | On the market |
| ClearRead CT Server 5.11.1 | 5.11.1 | M722C26103V260970 | — | On the market |
Similar devices
Other devices filed under FDA product code OEB (Lung Computed Tomography System, Computer-Aided Detection).
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- InferRead Lung CT.AI by Infervision Medical Technology Co., Ltd.