HeartSee

FDA 510(k) K143664 · University of Texas Medical School AT Houston

Substantially Equivalent

510(k) numberK143664

Submission

Device name
HeartSee
Applicant
University of Texas Medical School AT Houston
Houston, TX, US
Received
December 23, 2014
Decision date
April 14, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KPS – System, Tomography, Computed, Emission
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1200
Specialty
Radiology

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Questions and answers

When was HeartSee cleared by the FDA?

HeartSee (K143664) received a 510(k) decision of Substantially Equivalent on April 14, 2015, 112 days after the submission was received.

What is the product code of K143664?

The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.