Achieva, Ingenia, Ingenia CX, Ingenia Elition And Ingenia Ambition MR Systems

System, Nuclear Magnetic Resonance Imaging

Philips Medical Systems Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Achieva, Ingenia, Ingenia Cx, Ingenia Elition And Ingenia Ambition Mr Systems.

Pre-market Notification Details

Device IDK213583
510k NumberK213583
Device Name:Achieva, Ingenia, Ingenia CX, Ingenia Elition And Ingenia Ambition MR Systems
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684PC
ContactJan Van De Kerkhof
CorrespondentSusan Quick
Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best,  NL 5684PC
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-12
Decision Date2022-05-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838108646 K213583 000
00884838099456 K213583 000
00884838101135 K213583 000
00884838108653 K213583 000
00884838108684 K213583 000
00884838108714 K213583 000
00884838099463 K213583 000
00884838099470 K213583 000
00884838099487 K213583 000
00884838099500 K213583 000
00884838099494 K213583 000
00884838108608 K213583 000
00884838108615 K213583 000
00884838108622 K213583 000
00884838108639 K213583 000
00884838082618 K213583 000

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