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FDA 510(k)

X5 Digital Color Doppler Ultrasound System

K-Number: K160258 · 2016-04-01

Decision Date2016-04-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X5 Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2016-04-01 under 510(k) number K160258. 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 X5 Digital Color Doppler Ultrasound System?

X5 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K160258.

When did X5 Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

X5 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2016-04-01, under 510(k) number K160258.

Who is the listed applicant for X5 Digital Color Doppler Ultrasound System?

The FDA 510(k) record lists Sonoscape Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X5 Digital Color Doppler Ultrasound System?

The FDA product code for X5 Digital Color Doppler Ultrasound System 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.

Other records listing Sonoscape Medical Corp. as applicant

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.

View all 22 devices →

Related Devices (Code: IYN)

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.

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.