Company profile

Philips Medical Systems Nederland B.V.

Philips Medical Systems Nederland B.V. has 9 AI-enabled medical devices on the FDA list. The first decision was on August 6, 2021 and the most recent on March 17, 2026 (EchoNavigator R5.0). Its most common review panel is Radiology (9 devices).

9AI devices

2021First decision

2026Latest decision

1Specialties

Per year

20212022202320252026

Philips Medical Systems Nederland B.V. AI devices per year: 2021 1, 2022 2, 2023 1, 2025 1, 2026 4

By specialty

Radiology9

Related guides

Top radiology devices

Timeline

March 17, 2026 · 510(k) K253614EchoNavigator R5.0 · Radiology · QIH
March 5, 2026 · 510(k) K260169AV Cardiac CT · Radiology · JAK
February 23, 2026 · 510(k) K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades · Radiology · LNH
January 22, 2026 · 510(k) K253735AV Vascular · Radiology · QIH
June 4, 2025 · 510(k) K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System · Radiology · LNH
April 6, 2023 · 510(k) K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems · Radiology · LNH
May 16, 2022 · 510(k) K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems · Radiology · LNH
January 14, 2022 · 510(k) K210760Precise Image · Radiology · JAK
August 6, 2021 · 510(k) K211764Vereos PET/CT · Radiology · KPS