The following data is part of a premarket notification filed by Philips Medical Systems Technologies, Ltd. with the FDA for Illumeo System.
| Device ID | K173588 |
| 510k Number | K173588 |
| Device Name: | Illumeo System |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Medical Systems Technologies, Ltd. PO Box 325 Building 34 Haifa, IL 3100202 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Philips Medical Systems Technologies Ltd. 31 Haavoda Street Binyamina, IL 3100202 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087958 | K173588 | 000 |
| 00884838093997 | K173588 | 000 |