Philips Healthcare Informatics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2338-2020 | Class II | IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained profess | April 19, 2019 |
| Z-2252-2014 | Class II | Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measuremen | July 24, 2014 |
| Z-1646-2014 | Class II | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiolog | May 5, 2014 |
| Z-0269-2014 | Class II | Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used | October 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K182926 | IntelliSpace Radiology | December 6, 2018 |
| K111804 | INTELLISPACE PACS 4.X | July 28, 2011 |