The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Centricity Radiology Ra600/centricity Cardiology Ca1000/centricity Digital Hardcopy Workstation.
| Device ID | K042525 |
| 510k Number | K042525 |
| Device Name: | CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 800 BUSINESS CENTER DR. Mount Prospect, IL 60056 |
| Contact | Carol Alloian |
| Correspondent | Chantel Carson UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-09-17 |
| Decision Date | 2004-10-01 |
| Summary: | summary |