510(k) Report

Devices descending from K193215

11 later devices reach Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia…Philips Medical Systems Nederland B.V.2025019
+1K232030Ingenia Elition R5.7.1 SP4 MR SystemsPhilips Medical Systems Nederland B.V.202301
+1K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsPhilips Medical Systems Nederland B.V.2022539
+1K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiPhilips Medical Systems Nederland B.V.2022545
+1K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation20220—
+1K212673MR 5300Philips Medical Systems Nederland B.V.2021617
+2K230972Ingenia Elition and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023019
+2K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsPhilips Medical Systems Nederland B.V.2023217
+2K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.202245
+3K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR…Philips Medical Systems Nederland B.V.2025115
+4K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR…Philips Medical Systems Nederland B.V.20260—