The following data is part of a premarket notification filed by Philips Healthcare Informatics, Inc. with the FDA for Intellispace Pacs 4.x.
| Device ID | K111804 |
| 510k Number | K111804 |
| Device Name: | INTELLISPACE PACS 4.X |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS HEALTHCARE INFORMATICS, INC. 4100 E 3rd Ave Ste 101 Foster City, CA 94404 |
| Contact | Victoria S Mackinnon |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074781 | K111804 | 000 |