Atlas FDA

ACHIEVA 1.5T & INERA 1.5T FAMILY

FDA 510(k) clearance K052013 · decided 2005-08-02

Clearance details

K-number
K052013
Device name
ACHIEVA 1.5T & INERA 1.5T FAMILY
Applicant
Philips Medical Systems Nederland B.V.
Decision
Substantially Equivalent
Date received
2005-07-26
Decision date
2005-08-02
Days to decision
7 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
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Ph recall (Z-2163-2024)Philips North America Llc2024-06-27
SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Ph recall (Z-2164-2024)Philips North America Llc2024-06-27
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging i recall (Z-2165-2024)Philips North America Llc2024-06-27
Achieva 1.5T recall (Z-0389-2024)Philips North America Llc2023-11-21
Achieva 1.5T Conversion recall (Z-0390-2024)Philips North America Llc2023-11-21
Ingenia 1.5T CX recall (Z-0392-2024)Philips North America Llc2023-11-21
Intera 1.5T recall (Z-0393-2024)Philips North America Llc2023-11-21
Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System recall (Z-0887-2019)Philips Medical Systems Nederlands2019-02-22
Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System recall (Z-0888-2019)Philips Medical Systems Nederlands2019-02-22
Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging Sys recall (Z-0889-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging Syste recall (Z-0890-2019)Philips Medical Systems Nederlands2019-02-22
Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging Syste recall (Z-0891-2019)Philips Medical Systems Nederlands2019-02-22
Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging recall (Z-0892-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System recall (Z-0894-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System recall (Z-0895-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging Sys recall (Z-0896-2019)Philips Medical Systems Nederlands2019-02-22
Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System recall (Z-0899-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging Syst recall (Z-0908-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System recall (Z-0909-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System recall (Z-0912-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System recall (Z-0915-2019)Philips Medical Systems Nederlands2019-02-22
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 7 recall (Z-1433-2018)Philips Electronics North America Corporation2018-04-18
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, recall (Z-1435-2018)Philips Electronics North America Corporation2018-04-18
Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL recall (Z-2461-2010)Philips Medical Systems North America Co. Phillips2010-09-22