Cleared Traditional

Definium Tempo Select

K250788 · Ge Hualun Medical Systems Co. , Ltd. · Radiology
Aug 2025
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K250788 is an FDA 510(k) clearance for the Definium Tempo Select, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 28, 2025, 167 days after receiving the submission on March 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K250788 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2025
Decision Date August 28, 2025
Days to Decision 167 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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