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FDA 510(k)

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)

K-Number: K244054 · 2025-02-28

ApplicantQuality Electrodynamics
Decision Date2025-02-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is a medical device manufactured by Quality Electrodynamics. It received FDA 510(k) clearance on 2025-02-28 under approval number K244054. 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 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is a medical device that received FDA 510(k) clearance on 2025-02-28. It is manufactured by Quality Electrodynamics. The 510(k) number is K244054.

When was 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) approved by the FDA?

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) received FDA 510(k) clearance on 2025-02-28, under approval number K244054.

What company makes 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is manufactured by Quality Electrodynamics.

What is the FDA product code for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)?

The FDA product code for 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) is MOS.

Related Clinical Trials

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Related PubMed Literature

PMID: 41302949 Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of clinical medicine (2025)

Other Devices by Quality Electrodynamics

K233652Contour Hand/Wrist (Q7000232) K233656Contour Shoulder

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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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