The following data is part of a premarket notification filed by R2 Technology, Inc. with the FDA for Imagechecker-ct Software Package With Filling Defect Indicator.
| Device ID | K041380 |
| 510k Number | K041380 |
| Device Name: | IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | R2 TECHNOLOGY, INC. 1195 W. FREMONT AVE. Sunnyvale, CA 94087 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Denise Leung Klinker UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-05-25 |
| Decision Date | 2004-06-08 |
| Summary: | summary |