Enterprise Imaging XERO Viewer 8.1— 510(k) K170434
Substantially EquivalentAgfa Healthcare N.V.
FDA 510(k) clearance K170434 for Enterprise Imaging XERO Viewer 8.1, Substantially Equivalent on 2017-07-03. Applicant: Agfa Healthcare N.V.. Device class: 2.
Clearance details
- Applicant
- Agfa Healthcare N.V.
- 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
- Mortsel, BE
Recent devices under product code LLZ
view allMore clearances from Agfa Healthcare N.V.
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 K170434
K-number listed on FDA's recall record- Z-0055-2025 — Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)
- Z-1004-2023 — Agfa HealthCare Enterprise Imaging XERO Viewer
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170434.
Data sourced from openFDA. This site is unofficial and independent of the FDA.