CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY— 510(k) K063628

Clearance details

Applicant

Ge Healthcare Integrated IT Solutions

Product code

Code LLZ

Device class

Class 2

Regulation

21 CFR 892.2050

Advisory panel

Radiology

Date received

2006-12-06

Decision date

2006-12-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Barrington, IL, US

• K262060 — 3D-RD-S2026-09-04
• K261500 — KBA3D (v2.4.0)2026-08-17
• K262449 — AdvaView2026-08-14
• K261916 — NeuroQuant PET2026-08-12
• K260936 — RadioViewAI2026-07-31

• K121387 — CENTRICITY PACS-IW2012-06-05
• K112570 — CENTRICITY CARDIO IMAGING2011-11-30
• K111614 — CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE2011-09-26

Death

13

Total

13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1485-2025 — 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; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.Class II·Ongoing·GE Healthcare·20250219
• Z-1486-2025 — 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) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.Class II·Ongoing·GE Healthcare·20250219
• Z-1231-2022 — Centricity Radiology RA600Class II·Ongoing·GE Healthcare, LLC·20220428

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063628.