Last synced on 20 December 2024 at 11:05 pm

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183186
510(k) Type
Traditional
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/8/2019
Days to Decision
81 days
Submission Type
Summary

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183186
510(k) Type
Traditional
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
2/8/2019
Days to Decision
81 days
Submission Type
Summary