The following data is part of a premarket notification filed by Riverain Medical Group with the FDA for Softview, Model 2.01.
| Device ID | K092363 |
| 510k Number | K092363 |
| Device Name: | SOFTVIEW, MODEL 2.01 |
| Classification | System, Image Processing, Radiological |
| Applicant | RIVERAIN MEDICAL GROUP 3020 SOUTH TECH BLVD. Miamisburg, OH 45342 -4860 |
| Contact | Jennifer Vetter |
| Correspondent | Jennifer Vetter RIVERAIN MEDICAL GROUP 3020 SOUTH TECH BLVD. Miamisburg, OH 45342 -4860 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2010-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M722XD25114B250640 | K092363 | 000 |
| M722XC25114B250640 | K092363 | 000 |
| M722X25122B250640 | K092363 | 000 |