Mckesson Information Solutions LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0042-2015 | Class II | McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data | August 27, 2014 |
| Z-0093-2015 | Class II | McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemody | June 25, 2014 |
| Z-0976-2014 | Class II | Horizon Medical Imaging, Picture Archive Communication System (PACS). | December 23, 2013 |
| Z-0556-2014 | Class II | McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). | October 15, 2013 |
| Z-2318-2013 | Class II | McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 | September 4, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102263 | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 | May 5, 2011 |