READY VIEW— 510(k) K110573
Substantially EquivalentGe Healthcare (Ge Medical Systems Scs)
FDA 510(k) clearance K110573 for READY VIEW, Substantially Equivalent on 2011-05-03. Applicant: Ge Healthcare (Ge Medical Systems Scs). Device class: 2.
Clearance details
- Applicant
- Ge Healthcare (Ge Medical Systems Scs)
- 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
- Traditional
- Location
- Waukesha, WI, US
Recent devices under product code LLZ
view allMore clearances from Ge Healthcare (Ge Medical Systems Scs)
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 K110573
K-number listed on FDA's recall record- Z-2241-2013 — GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110573.
Data sourced from openFDA. This site is unofficial and independent of the FDA.