Skip to content

HeartSee

by University of Texas Medical School AT Houston 510(k)

Active United States

510(k) K143664

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK143664 Date14 Apr 2015ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from University of Texas Medical School AT Houston

  • Cfr Quant

    Class II