FDA 510(k)

GATED MIBI 3-D EJECTION FRACTION PROCESSING

K-Number: K961597 · 1996-09-04

ApplicantTrionix Research Laboratory, Inc.

Decision Date1996-09-04

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GATED MIBI 3-D EJECTION FRACTION PROCESSING is the device name listed in this FDA 510(k) record. The listed applicant is Trionix Research Laboratory, Inc.. It received FDA 510(k) clearance on 1996-09-04 under 510(k) number K961597. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GATED MIBI 3-D EJECTION FRACTION PROCESSING?

GATED MIBI 3-D EJECTION FRACTION PROCESSING is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is Trionix Research Laboratory, Inc.. The 510(k) number is K961597.

When did GATED MIBI 3-D EJECTION FRACTION PROCESSING receive FDA 510(k) clearance?

GATED MIBI 3-D EJECTION FRACTION PROCESSING received FDA 510(k) clearance on 1996-09-04, under 510(k) number K961597.

Who is the listed applicant for GATED MIBI 3-D EJECTION FRACTION PROCESSING?

The FDA 510(k) record lists Trionix Research Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GATED MIBI 3-D EJECTION FRACTION PROCESSING?

The FDA product code for GATED MIBI 3-D EJECTION FRACTION PROCESSING is KPS.

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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.