Change Healthcare Enterprise Viewer— 510(k) K181185
Substantially EquivalentChange Healthcare Canada Company
FDA 510(k) clearance K181185 for Change Healthcare Enterprise Viewer, Substantially Equivalent on 2018-08-29. Applicant: Change Healthcare Canada Company. Device class: 2.
Clearance details
- Applicant
- Change Healthcare Canada Company
- 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
- Richmond, CA
Recent devices under product code LLZ
view allMore clearances from Change Healthcare Canada Company
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 K181185
K-number listed on FDA's recall record- Z-1773-2021 — Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
- Z-1508-2021 — Change Healthcare Enterprise Viewer
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181185.
Data sourced from openFDA. This site is unofficial and independent of the FDA.