The following data is part of a premarket notification filed by Riverain Technologies with the FDA for Clearread +confirm.
| Device ID | K123526 |
| 510k Number | K123526 |
| Device Name: | CLEARREAD +CONFIRM |
| Classification | System, Image Processing, Radiological |
| Applicant | RIVERAIN TECHNOLOGIES 3020 SOUTH TECH BLVD. Miamisburg, OH 45324 |
| Contact | Jennifer Butsch |
| Correspondent | Jennifer Butsch RIVERAIN TECHNOLOGIES 3020 SOUTH TECH BLVD. Miamisburg, OH 45324 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-15 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M722XD25114E250640 | K123526 | 000 |
| M722XC25114E250640 | K123526 | 000 |
| M722X25122E250640 | K123526 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CLEARREAD +CONFIRM 85539597 4515159 Live/Registered |
RIVERAIN TECHNOLOGIES, LLC 2012-02-10 |