ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T— 510(k) K110151
Substantially EquivalentPhilips Health Care
FDA 510(k) clearance K110151 for ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T, Substantially Equivalent on 2011-03-22. Applicant: Philips Health Care. Device class: 2.
Clearance details
- Applicant
- Philips Health Care
- Product code
- Code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Recent devices under product code LNH
view allMore clearances from Philips Health Care
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K110151
K-number listed on FDA's recall record- Z-2411-2021 — 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 orientation of the internal structure of the head, body, or extremities Models: 781341 781396
- Z-2346-2021 — 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 orientation of the internal structure of the head, body or extremities Model Number: 781277 (OUS)
- Z-0924-2019 — MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System
- Z-0925-2019 — MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System
- Z-0926-2019 — MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System
- Z-0825-2017 — 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 imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
- Z-0325-2016 — 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.
- Z-2237-2014 — 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 that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
- Z-1862-2014 — Ingenia 3.0T R5, magnetic resonance imaging system.
- Z-1863-2014 — Ingenia 1.5T R5, magnetic resonance imaging system.
- Z-1864-2014 — Ingenia 3.0T, magnetic resonance imaging system.
- Z-1865-2014 — Ingenia 1.5T, magnetic resonance imaging system.
- Z-1826-2014 — 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 optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
- Z-1827-2014 — 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 optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.
- Z-0135-2016 — 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 images and/or spectra in any orientation of the internal structure of the head, body, or extremities.
- Z-1678-2014 — 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 imaging data viewing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110151.
Data sourced from openFDA. This site is unofficial and independent of the FDA.