IMAGEN3D

FDA 510(k) K122241 · Cardiovascular Imaging Technologies

Substantially Equivalent

510(k) numberK122241

Submission

Device name
IMAGEN3D
Applicant
Cardiovascular Imaging Technologies
Lenexa, KS, US
Received
July 27, 2012
Decision date
October 24, 2012
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 IMAGEN3D cleared by the FDA?

IMAGEN3D (K122241) received a 510(k) decision of Substantially Equivalent on October 24, 2012, 89 days after the submission was received.

What is the product code of K122241?

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