The following data is part of a premarket notification filed by Philips Healthcare Informatics, Inc. with the FDA for Intellispace Radiology.
| Device ID | K182926 |
| 510k Number | K182926 |
| Device Name: | IntelliSpace Radiology |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Healthcare Informatics, Inc. 4430 Rosewood Drive, Suite 200 Pleasanton, CA 94588 |
| Contact | Paige Gridack |
| 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 | 2018-10-22 |
| Decision Date | 2018-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838091740 | K182926 | 000 |
| 00884838123809 | K182926 | 000 |