IMPAX NEXT GENERATION— 510(k) K111945
Substantially EquivalentAgfa Healthcare N.V.
FDA 510(k) clearance K111945 for IMPAX NEXT GENERATION, Substantially Equivalent on 2011-08-05. 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 K111945
K-number listed on FDA's recall record- Z-0101-2019 — Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
- Z-0919-2014 — IMPAX RIS QDOC 5.8
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111945.
Data sourced from openFDA. This site is unofficial and independent of the FDA.