The following data is part of a premarket notification filed by Philips Medical Systems Nederland Bv with the FDA for I4 (integrated Intelligent Imaging Informatics) System.
| Device ID | K160315 |
| 510k Number | K160315 |
| Device Name: | I4 (Integrated Intelligent Imaging Informatics) System |
| Classification | System, Image Processing, Radiological |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND BV VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Ilana Ben Moshe |
| 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 | 2016-02-05 |
| Decision Date | 2016-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838074743 | K160315 | 000 |