Optima Nm/Ct 640

FDA 510(k) K121019 · GE Healthcare

Substantially Equivalent

510(k) numberK121019

Submission

Device name
Optima Nm/Ct 640
Applicant
GE Healthcare
Tirat Hacarmel, IL
Received
April 4, 2012
Decision date
April 19, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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 Optima Nm/Ct 640 cleared by the FDA?

Optima Nm/Ct 640 (K121019) received a 510(k) decision of Substantially Equivalent on April 19, 2012, 15 days after the submission was received.

What is the product code of K121019?

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