FDA 510(k)

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

K-Number: K241554 · 2024-10-24

ApplicantTelefield Medical Imaging (Shenzhen) Limited

Decision Date2024-10-24

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is the device name listed in this FDA 510(k) record. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K241554. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Telefield Medical Imaging (Shenzhen) Limited. The 510(k) number is K241554.

When did Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) receive FDA 510(k) clearance?

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K241554.

Who is the listed applicant for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA 510(k) record lists Telefield Medical Imaging (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)?

The FDA product code for Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) is IYN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.