510(k) Report

Devices descending from K213516

5 later devices reach Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223442MR 5300 and MR 7700 R11 MR SystemsPhilips Medical Systems Nederlands B.V.202245
+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
+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—