The following data is part of a premarket notification filed by Riverain Medical Group,llc with the FDA for Deltaview Model 2.1.
| Device ID | K111776 |
| 510k Number | K111776 |
| Device Name: | DELTAVIEW MODEL 2.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | RIVERAIN MEDICAL GROUP,LLC 3020 SOUTH TECH BLVD. Miamisburg, OH 45342 -4860 |
| Contact | Jennifer V Butsch |
| Correspondent | Jennifer V Butsch RIVERAIN MEDICAL GROUP,LLC 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 | 2011-06-23 |
| Decision Date | 2011-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M722XC25114T250640 | K111776 | 000 |
| M722X25122T250640 | K111776 | 000 |