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FDA 510(k)

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

K-Number: K183186 · 2019-02-08

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2019-02-08
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2019-02-08 under approval number K183186. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 is a medical device that received FDA 510(k) clearance on 2019-02-08. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K183186.

When was Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 approved by the FDA?

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 received FDA 510(k) clearance on 2019-02-08, under approval number K183186.

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

Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24?

The FDA product code for Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 is MOS.

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Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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