CENTRICITY PACS WEB DIAGNOSTIC— 510(k) K083018
Substantially EquivalentGe Healthcare Dynamic Imaging Solutions
FDA 510(k) clearance K083018 for CENTRICITY PACS WEB DIAGNOSTIC, Substantially Equivalent on 2008-11-14. 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 K083018
K-number listed on FDA's recall record- Z-1782-2017 — Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
- Z-0118-2014 — 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. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083018.
Data sourced from openFDA. This site is unofficial and independent of the FDA.