Class Class II
Ingenia Elition and MR 7700 MR Systems (K230972)
Description
Ingenia Elition and MR 7700 MR Systems by Philips Medical Systems Nederland B.V., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230972
Clearance Date2023-04-28
Clearance TypeSpecial
Product CodeLNH
Regulation Number892.1000
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230972
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Ingenia Elition and MR 7700 MR Systems (K230972) cites 9 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands ... | 2022 |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia A... | Philips Medical Systems Nederland B.V. | 2022 |
| K172920 | 3D APT | Philips Medical Systems Nederland B.V. | 2018 |
| K143253 | O-MAR | Philips Medical Systems Nederland B.V. | 2015 |
| K143128 | mDIXON XD | Philips Medical Systems Nederlands ... | 2015 |
| K140666 | MR ELASTOGRAPHY | Philips Medical Systems Nederland B.V. | 2014 |
| K133526 | MDIXON-QUANT | Philips Medical Systems Nederland B.V. | 2014 |
| K131241 | SWIP | Philips Medical Systems Nederland B.V. | 2013 |
| K102344 | MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHI... | Philips Medical Systems Nederland B.V. | 2010 |
Trace the full predicate network for K230972
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.