Atlas FDA

ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T

FDA 510(k) clearance K110151 · decided 2011-03-22

Clearance details

K-number
K110151
Device name
ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Applicant
Philips Health Care
Decision
Substantially Equivalent
Date received
2011-01-18
Decision date
2011-03-22
Days to decision
63 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Bothell, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System recall (Z-0924-2019)Philips Medical Systems Nederlands2019-02-22
MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System recall (Z-0925-2019)Philips Medical Systems Nederlands2019-02-22
MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System recall (Z-0926-2019)Philips Medical Systems Nederlands2019-02-22
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neur recall (Z-0825-2017)Philips Electronics North America Corporation2016-12-19
Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5 recall (Z-0325-2016)Philips Medical Systems, Inc.2015-11-23
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal recall (Z-2237-2014)Philips Medical Systems (Cleveland) Inc2014-08-14
Ingenia 3.0T R5, magnetic resonance imaging system. recall (Z-1862-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 1.5T R5, magnetic resonance imaging system. recall (Z-1863-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 3.0T, magnetic resonance imaging system. recall (Z-1864-2014)Philips Medical Systems, Inc.2014-06-24
Ingenia 1.5T, magnetic resonance imaging system. recall (Z-1865-2014)Philips Medical Systems, Inc.2014-06-24
Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Produc recall (Z-1826-2014)Philips Medical Systems, Inc.2014-06-18
Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product recall (Z-1827-2014)Philips Medical Systems, Inc.2014-06-18
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030 recall (Z-1678-2014)Philips Medical Systems (Cleveland) Inc2014-06-02
Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of elec recall (Z-1125-2012)Philips Medical Systems Nederlands2012-02-29
Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. Syst recall (Z-0293-2012)Philips Medical Systems (Cleveland) Inc2011-11-28