The following data is part of a premarket notification filed by R4 Llc with the FDA for R4 Acert Ultrasound Reporting System.
| Device ID | K101898 |
| 510k Number | K101898 |
| Device Name: | R4 ACERT ULTRASOUND REPORTING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | R4 LLC 17999 FOLTZ PARKWAY Strongsville, OH 44149 |
| Contact | Cristian Negrila |
| Correspondent | Cristian Negrila R4 LLC 17999 FOLTZ PARKWAY Strongsville, OH 44149 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2011-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857926006001 | K101898 | 000 |