ClearanceBrief
510(k) K110151 ยท LNH System, Nuclear Magnetic Resonance Imaging

ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

ApplicantPhilips Health Care, Bothell WA, US
DecisionSubstantially Equivalent, Mar 22, 2011
ReceivedJan 18, 2011
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K110151

DateFirm and productCodeLinked 510(k)
Sep 25, 2026Philips North America
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 7821
Open, Classified		 LNHNone listed
Sep 18, 2026Philips North America Llc
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (
Open, Classified		 LNHNone listed
Aug 11, 2021Philips North America Llc
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orient
Completed		 LNHNone listed
Jul 30, 2021Philips North America Llc
Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientati
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Feb 22, 2019Philips Medical Systems Nederlands
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
Terminated		 LNHNone listed
Dec 19, 2016Philips Electronics North America Corporation
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR
Terminated		 LNHNone listed
Nov 23, 2015Philips Medical Systems, Inc.
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
Terminated		 LNHNone listed
Aug 14, 2014Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server
Terminated		 JAKNone listed
Jun 24, 2014Philips Medical Systems, Inc.
Ingenia 3.0T R5, magnetic resonance imaging system.
Terminated		 LNHNone listed
Jun 24, 2014Philips Medical Systems, Inc.
Ingenia 1.5T R5, magnetic resonance imaging system.
Terminated		 LNHNone listed
Jun 24, 2014Philips Medical Systems, Inc.
Ingenia 3.0T, magnetic resonance imaging system.
Terminated		 LNHNone listed
Jun 24, 2014Philips Medical Systems, Inc.
Ingenia 1.5T, magnetic resonance imaging system.
Terminated		 LNHNone listed
Jun 18, 2014Philips Medical Systems, Inc.
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an
Terminated		 LNHNone listed
Jun 18, 2014Philips Medical Systems, Inc.
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an o
Terminated		 LNHNone listed
Jun 2, 2014Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips Medical Systems. A medical software system for diagnostic imagin
Terminated		 KPSNone listed
May 5, 2014Philips Medical Systems, Inc.
All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic
Terminated		 LNHNone listed
Feb 29, 2012Philips Medical Systems Nederlands
Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
Terminated		 LNHNone listed
Nov 28, 2011Philips Medical Systems (Cleveland) Inc
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is
Terminated		 LNHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.