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FDA 510(k)

ULTRASIM CT SYSTEM

K-Number: K001088 · 2000-06-22

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2000-06-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASIM CT 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 2000-06-22 under 510(k) number K001088. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASIM CT SYSTEM?

ULTRASIM CT SYSTEM is a medical device that received FDA 510(k) clearance on 2000-06-22. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K001088.

When did ULTRASIM CT SYSTEM receive FDA 510(k) clearance?

ULTRASIM CT SYSTEM received FDA 510(k) clearance on 2000-06-22, under 510(k) number K001088.

Who is the listed applicant for ULTRASIM CT 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 ULTRASIM CT SYSTEM?

The FDA product code for ULTRASIM CT SYSTEM is JAK.

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Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: JAK)

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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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