Cleared Traditional

K250648 - Philips iCT CT system
(FDA 510(k) Clearance)

K250648 · Philips Medical Systems Nederland B.V. · Radiology

Jun 2025

Decision

115d

Days

Class 2

Risk

K250648 is an FDA 510(k) clearance for the Philips iCT CT system, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems Nederland B.V. (Haifa, IL). The FDA issued a Cleared decision on June 27, 2025, 115 days after receiving the submission on March 4, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K250648 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2025
Decision Date	June 27, 2025
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF