The following data is part of a premarket notification filed by Philips Healthcare (suzhou) Co., Ltd with the FDA for Ds Torsocardiac 1.5t, Ds Msk S 1.5t, Ds Msk M 1.5t.
| Device ID | K212864 |
| 510k Number | K212864 |
| Device Name: | DS TorsoCardiac 1.5T, DS MSK S 1.5T, DS MSK M 1.5T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Contact | Seaman Shao |
| Correspondent | Seaman Shao Philips Healthcare (Suzhou) Co., Ltd No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, CN 215024 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-08 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838096837 | K212864 | 000 |
| 00884838096820 | K212864 | 000 |
| 00884838096813 | K212864 | 000 |