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FDA 510(k)

ENCOMPASS SOFTWARE PACKAGE

K-Number: K053043 · 2005-11-18

ApplicantToshiba America Medical Systems, In.C
Decision Date2005-11-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ENCOMPASS SOFTWARE PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K053043. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENCOMPASS SOFTWARE PACKAGE?

ENCOMPASS SOFTWARE PACKAGE is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K053043.

When did ENCOMPASS SOFTWARE PACKAGE receive FDA 510(k) clearance?

ENCOMPASS SOFTWARE PACKAGE received FDA 510(k) clearance on 2005-11-18, under 510(k) number K053043.

Who is the listed applicant for ENCOMPASS SOFTWARE PACKAGE?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENCOMPASS SOFTWARE PACKAGE?

The FDA product code for ENCOMPASS SOFTWARE PACKAGE is LLZ.

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Other records listing Toshiba America Medical Systems, In.C as applicant

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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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