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 | K212441 |
| 510k Number | K212441 |
| 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 | Shiguang An |
| 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 | 2021-08-04 |
| Decision Date | 2022-04-27 |