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FDA 510(k)

1.5T and 3.0T 16 CH GE Shoulder Coils

K-Number: K162001 · 2016-08-31

ApplicantInvivo Corporation
Decision Date2016-08-31
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T and 3.0T 16 CH GE Shoulder Coils is a medical device manufactured by Invivo Corporation. It received FDA 510(k) clearance on 2016-08-31 under approval number K162001. 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 1.5T and 3.0T 16 CH GE Shoulder Coils?

1.5T and 3.0T 16 CH GE Shoulder Coils is a medical device that received FDA 510(k) clearance on 2016-08-31. It is manufactured by Invivo Corporation. The 510(k) number is K162001.

When was 1.5T and 3.0T 16 CH GE Shoulder Coils approved by the FDA?

1.5T and 3.0T 16 CH GE Shoulder Coils received FDA 510(k) clearance on 2016-08-31, under approval number K162001.

What company makes 1.5T and 3.0T 16 CH GE Shoulder Coils?

1.5T and 3.0T 16 CH GE Shoulder Coils is manufactured by Invivo Corporation.

What is the FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils?

The FDA product code for 1.5T and 3.0T 16 CH GE Shoulder Coils is MOS.

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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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