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FDA 510(k)

3.0T Air MP M, 3.0T Air MP L

K-Number: K182504 · 2018-10-12

ApplicantGe Healthcare Coils (Usa Instruments, Inc.)
Decision Date2018-10-12
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0T Air MP M, 3.0T Air MP L is a medical device manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2018-10-12 under approval number K182504. 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 3.0T Air MP M, 3.0T Air MP L?

3.0T Air MP M, 3.0T Air MP L is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K182504.

When was 3.0T Air MP M, 3.0T Air MP L approved by the FDA?

3.0T Air MP M, 3.0T Air MP L received FDA 510(k) clearance on 2018-10-12, under approval number K182504.

What company makes 3.0T Air MP M, 3.0T Air MP L?

3.0T Air MP M, 3.0T Air MP L is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.).

What is the FDA product code for 3.0T Air MP M, 3.0T Air MP L?

The FDA product code for 3.0T Air MP M, 3.0T Air MP L is MOS.

Other Devices by Ge Healthcare Coils (Usa Instruments, Inc.)

K172695AIR Anterior Array, AIR Posterior Array K16320548CH Head Coil K18066648CH Head Coil K2233783.0T 16ch AIR AA K2537383.0T AIR 32CH HNA

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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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