MCKESSON RADIOLOGY— 510(k) K140909
Substantially EquivalentMckesson Medical Imaging Company
FDA 510(k) clearance K140909 for MCKESSON RADIOLOGY, Substantially Equivalent on 2014-07-02. Applicant: Mckesson Medical Imaging Company. Device class: 2.
Clearance details
- Applicant
- Mckesson Medical Imaging 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
- Alpharetta, GA, US
Recent devices under product code LLZ
view allMore clearances from Mckesson Medical Imaging 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 K140909
K-number listed on FDA's recall record- Z-0030-2026 — Change Healthcare Radiology Solutions software version 14.2.2
- Z-0237-2024 — Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
- Z-0072-2021 — Change Healthcare Radiology Solutions 14.0
- Z-1396-2017 — McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140909.
Data sourced from openFDA. This site is unofficial and independent of the FDA.