The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Philips Incisive Ct.
Device ID | K180015 |
510k Number | K180015 |
Device Name: | Philips Incisive CT |
Classification | System, X-ray, Tomography, Computed |
Applicant | Philips Healthcare (Suzhou) Co., Ltd. No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
Contact | Gordon Shu |
Correspondent | Shiguang An Philips Healthcare (Suzhou) Co., Ltd. No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-02 |
Decision Date | 2018-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00884838085015 | K180015 | 000 |
00884838105508 | K180015 | 000 |