510(k) K063628 ยท LLZ System, Image Processing, Radiological
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
| Applicant | Ge Healthcare Integrated IT Solutions, Barrington IL, US |
| Decision | Substantially Equivalent, Dec 26, 2006 |
| Received | Dec 6, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063628
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2025 | GE Healthcare GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers:
1) 2022296-001;
2) 2033901-001;
3) 2038437-001;
4) 2038437-011;
5) 2038437-012;
6) 2038437-013;
7) 2038437-014;
8) 2038437-0XX Open, Classified |
LLZ | None listed |
| Mar 28, 2025 | GE Healthcare GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers:
1) 2033901-001;
2) 2038437-001;
3) 2038437-009;
4) 2038437-014;
5) 2038437-015 ;
6) 2038437-0XX;
7) 2109571-007;
8) 2109571 Open, Classified |
LLZ | None listed |
| Jun 3, 2022 | GE Healthcare, LLC Centricity Radiology RA600 Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.