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FDA 510(k)

EchoPAC Software Only / EchoPAC Plug-in

K-Number: K251342 · 2025-07-16

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2025-07-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EchoPAC Software Only / EchoPAC Plug-in is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-07-16 under approval number K251342. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EchoPAC Software Only / EchoPAC Plug-in?

EchoPAC Software Only / EchoPAC Plug-in is a medical device that received FDA 510(k) clearance on 2025-07-16. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K251342.

When was EchoPAC Software Only / EchoPAC Plug-in approved by the FDA?

EchoPAC Software Only / EchoPAC Plug-in received FDA 510(k) clearance on 2025-07-16, under approval number K251342.

What company makes EchoPAC Software Only / EchoPAC Plug-in?

EchoPAC Software Only / EchoPAC Plug-in is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for EchoPAC Software Only / EchoPAC Plug-in?

The FDA product code for EchoPAC Software Only / EchoPAC Plug-in is QIH.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

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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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