The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd. with the FDA for Prodiva 1.5t Cx And Prodiva 1.5t Cs R5.4.
| Device ID | K173507 |
| 510k Number | K173507 |
| Device Name: | Prodiva 1.5T CX And Prodiva 1.5T CS R5.4 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou, CN 215024 |
| Contact | Gordon Shu |
| Correspondent | Jacky Shi Philips Healthcare (Suzhou) Co., Ltd. No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou, CN 215024 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-13 |
| Decision Date | 2018-06-15 |
| Summary: | summary |