Computer, Diagnostic, Pre-Programmed, Single Function

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K944720 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Clinical Diagnostic Software

  Class II

  FDA 510(k) K970288 Active Cleared 24 Apr 1997

• Cequal(Tm) Quanitative Analysis Cardiolite(R) Spec

  Class II

  FDA 510(k) K914296 Active Cleared 27 Nov 1991

• Ctq - Cedars-Sinai Quantitative Thallium-201 Analy

  Class II

  FDA 510(k) K882271 Active Cleared 3 Nov 1988

• Cequal-Quantitative Analysis

  Class II

  FDA 510(k) K942363 Active Cleared 16 Sep 1994

• Cedars-Sinai Quantitative TI-201 Analysis CTQ 2.0

  Class II

  FDA 510(k) K905222 Active Cleared 26 Dec 1990

• Modified Cedars-Sinai Quanti Thallium-201 Analysis

  Class II

  FDA 510(k) K892397 Active Cleared 27 Oct 1989

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