The following data is part of a premarket notification filed by R2 Technology, Inc. with the FDA for R2 Family Of Image Display Units With R2 Uniform Display Software.
| Device ID | K050667 |
| 510k Number | K050667 |
| Device Name: | R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | R2 TECHNOLOGY, INC. 1195 WEST FREMONT AVE. Sunnyvale, CA 94087 |
| Contact | Richard Ball |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-15 |
| Decision Date | 2005-03-29 |
| Summary: | summary |