CENTRICITY PACS— 510(k) K110875
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K110875 for CENTRICITY PACS, Substantially Equivalent on 2011-05-05. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- Product code
- Product code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Barrington, IL, US
Recent devices under product code LLZ
view allMore clearances from GE Healthcare
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110875
K-number listed on FDA's recall record- Z-3169-2026 — Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
- Z-3168-2026 — Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
- Z-3166-2026 — Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
- Z-3171-2026 — Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All versions
- Z-3167-2026 — Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
- Z-3170-2026 — Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
- Z-3214-2024 — GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
- Z-1466-2022 — Centricity PACS Software Version 7.0 SP0.0.4.7
- Z-1233-2022 — Centricity PACS RA1000
- Z-1911-2019 — Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110875.
Data sourced from openFDA. This site is unofficial and independent of the FDA.