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 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| M722CD25211V252110 | K161201 | 000 | 
| M722CC25211V252110 | K161201 | 000 | 
| M722C25211V252110 | K161201 | 000 |