CENTRICITY PACS IW— 510(k) K082318
Substantially EquivalentGe Healthcare Dynamic Imaging Solutions
FDA 510(k) clearance K082318 for CENTRICITY PACS IW, Substantially Equivalent on 2008-08-25. Applicant: Ge Healthcare Dynamic Imaging Solutions. Device class: 2.
Clearance details
- Applicant
- Ge Healthcare Dynamic Imaging Solutions
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Monroe, CT, US
Recent devices under product code LLZ
view allMore clearances from Ge Healthcare Dynamic Imaging Solutions
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 K082318
K-number listed on FDA's recall record- Z-0138-2024 — Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
- Z-1502-2023 — Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
- Z-1781-2019 — GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x
- Z-1302-2018 — GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
- Z-0023-2016 — Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.