3.0T AIR 32CH HNA
K-Number: K253738 · 2026-01-23
Decision Date2026-01-23
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
3.0T AIR 32CH HNA is a medical device manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). It received FDA 510(k) clearance on 2026-01-23 under approval number K253738. 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 32CH HNA?
3.0T AIR 32CH HNA is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.). The 510(k) number is K253738.
When was 3.0T AIR 32CH HNA approved by the FDA?
3.0T AIR 32CH HNA received FDA 510(k) clearance on 2026-01-23, under approval number K253738.
What company makes 3.0T AIR 32CH HNA?
3.0T AIR 32CH HNA is manufactured by Ge Healthcare Coils (Usa Instruments, Inc.).
What is the FDA product code for 3.0T AIR 32CH HNA?
The FDA product code for 3.0T AIR 32CH HNA is MOS.
Other Devices by Ge Healthcare Coils (Usa Instruments, Inc.)
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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.