The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Pacs.
| Device ID | K110875 |
| 510k Number | K110875 |
| Device Name: | CENTRICITY PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 540 W. NORTHWEST HIGHWAY Barrington, IL 60010 |
| Contact | Cheryl Bork |
| Correspondent | Ned Devine 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 | 2011-03-30 |
| Decision Date | 2011-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104821 | K110875 | 000 |
| 00840682145572 | K110875 | 000 |
| 00840682124430 | K110875 | 000 |
| 00840682104807 | K110875 | 000 |
| 00840682145558 | K110875 | 000 |
| 00840682124447 | K110875 | 000 |