The following data is part of a premarket notification filed by Ge Healthcare Integrated It Solutions with the FDA for Centricity Radiology Ra600, Cardiology Ca1000 And Digital Hardcopy.
| Device ID | K063628 |
| 510k Number | K063628 |
| Device Name: | CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW HIGHWAY Barrington, IL 60010 |
| Contact | Karen M Lunde |
| Correspondent | Silvia Ankova 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 | 2006-12-06 |
| Decision Date | 2006-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682125260 | K063628 | 000 |