Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T— 510(k) K232021
Substantially EquivalentPhilips Healthcare (Suzhou) Co., Ltd.
FDA 510(k) clearance K232021 for Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T, Substantially Equivalent on 2023-09-01. Applicant: Philips Healthcare (Suzhou) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Philips Healthcare (Suzhou) Co., Ltd.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
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More clearances from Philips Healthcare (Suzhou) Co., Ltd.
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