The following data is part of a premarket notification filed by R2 Technology, Inc. with the FDA for Imagechecker-ct Workstation.
| Device ID | K023003 |
| 510k Number | K023003 |
| Device Name: | IMAGECHECKER-CT WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | R2 TECHNOLOGY, INC. 1195 W. FREMONT AVE. Sunnyvale, CA 94087 |
| Contact | Kathy O'shaughnessy |
| Correspondent | Kathy O'shaughnessy R2 TECHNOLOGY, INC. 1195 W. FREMONT AVE. Sunnyvale, CA 94087 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260483290114 | K023003 | 000 |
| 04260483290091 | K023003 | 000 |