510(k) Report

FDA applicant

University of Texas Medical School AT Houston

Houston, TX2 decisions2012–20150 recalls

FDA records 2 decisions for University of Texas Medical School AT Houston (Houston, TX) from 2012 to 2015: 2 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided University of Texas Medical School AT Houston’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12015: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — University of Texas Medical School AT Houston by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KPSSystem, Tomography, Computed, Emission2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113754CFR QuantUniversity of Texas Medical School AT Houston · 20122cite it
  • K143664HeartSeeUniversity of Texas Medical School AT Houston · 20151cites it

What has FDA decided for it lately?

  • K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015
  • K113754CFR QuantUniversity of Texas Medical School AT Houston · 2012

All 2 as University of Texas Medical School AT Houston →

Other applicant names beginning “University”

FDA records each applicant name separately; these may or may not be the same firm.

The University of Chicago 2University of Utah Hospitals and Clinics 2University of Washington 2University of Michigan 2University of Utah, Department of Orthopaedics 2University of Utah/School of Medicine 1University of Texas, MD Anderson Cancer Center 1University of Wisconsin 1University of Otago 1University of Florida 1University Hospital (London) Development Corp. 1University of Texas Medical School AT Houston, Texas 1