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Kinetdx

by Siemens Medi Cal Solutions, Inc. 510(k)

Active United States

510(k) K041029

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041029 Date8 Jul 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1235-06 FDA Unclassified (pre-2012) initiated 6 Apr 2006

    The cardiologist's report comments may not be retained by the system due to a software bug.

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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