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 |