Cleared Abbreviated

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

K253648 · Philips Medical Systems Nederland B.V. · Radiology

Feb 2026

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K253648 is an FDA 510(k) clearance for the Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on February 23, 2026, 95 days after receiving the submission on November 20, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K253648 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2025
Decision Date	February 23, 2026
Days to Decision	95 days
Submission Type	Abbreviated
Review Panel	Radiology (RA)
Summary	Summary PDF