Device Classification Name |
coil, magnetic resonance, specialty
|
510(k) Number |
K233600 |
Device Name |
Smart Fit Knee 3.0T |
Applicant |
Philips Healthcare (Suzhou) Co., Ltd. |
No. 258, Zhongyuan Road, Suzhou Industrial Park |
Suzhou,
CN
215024
|
|
Applicant Contact |
Li Sherry |
Correspondent |
Philips Healthcare (Suzhou) Co., Ltd. |
No. 258, Zhongyuan Road, Suzhou Industrial Park |
Suzhou,
CN
215024
|
|
Correspondent Contact |
Li Sherry |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 11/09/2023 |
Decision Date | 02/05/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|