Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24— 510(k) K183186
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K183186 for Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24, Substantially Equivalent on 2019-02-08. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai United Imaging Healthcare 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
- Shanghai, CN
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More clearances from Shanghai United Imaging Healthcare Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.