The following data is part of a premarket notification filed by Riverain Technologies, Llc with the FDA for Clearread Ct.
| Device ID | K161201 |
| 510k Number | K161201 |
| Device Name: | ClearRead CT |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | RIVERAIN TECHNOLOGIES, LLC 3020 SOUTH TECH BLVD. Miamisburg, OH 45324 |
| Contact | Jennifer Butsch |
| Correspondent | Jennifer Butsch RIVERAIN TECHNOLOGIES, LLC 3020 SOUTH TECH BLVD. Miamisburg, OH 45324 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-09-09 |
| Summary: | summary |