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FDA 510(k)

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

K-Number: K162329 · 2016-09-14

Decision Date2016-09-14
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K162329. 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 CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Philips Health Care. The 510(k) number is K162329.

When did CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System receive FDA 510(k) clearance?

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-14, under 510(k) number K162329.

Who is the listed applicant for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System?

The FDA product code for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System is IYN.

Other records listing Philips Health Care 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 11 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

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