SET-5002

FDA 510(k) K240827 · Shimadzu Corporation Medical Systems Division

Substantially Equivalent

510(k) numberK240827

Submission

Device name
SET-5002
Applicant
Shimadzu Corporation Medical Systems Division
Kyoto, JP
Received
March 26, 2024
Decision date
May 24, 2024
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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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K251370Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional Canon Medical Systems Corporation12/01/2025SE
K251401PennPET Explorer Positron Emission TomographKPS · Traditional Trustees of the University of Pennsylvania11/25/2025SE
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Questions and answers

When was SET-5002 cleared by the FDA?

SET-5002 (K240827) received a 510(k) decision of Substantially Equivalent on May 24, 2024, 59 days after the submission was received.

What is the product code of K240827?

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