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FDA 510(k)

ARTIS ULTRASOUND IMAGING SYSTEM

K-Number: K853565 · 1986-06-30

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1986-06-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ARTIS ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1986-06-30 under 510(k) number K853565. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIS ULTRASOUND IMAGING SYSTEM?

ARTIS ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-30. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K853565.

When did ARTIS ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

ARTIS ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1986-06-30, under 510(k) number K853565.

Who is the listed applicant for ARTIS ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Philips Medical Systems (Cleveland), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTIS ULTRASOUND IMAGING SYSTEM?

The FDA product code for ARTIS ULTRASOUND IMAGING SYSTEM is IYO.

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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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