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ACHIEVA FAMILY

FDA 510(k) clearance K043147 · decided 2005-02-15

Clearance details

K-number
K043147
Device name
ACHIEVA FAMILY
Applicant
Philips Medical Systems North America Co.
Decision
Substantially Equivalent
Date received
2004-11-15
Decision date
2005-02-15
Days to decision
92 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
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 XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System recall (Z-0884-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System recall (Z-0893-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System recall (Z-0897-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System recall (Z-0905-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System recall (Z-0906-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System recall (Z-0907-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System recall (Z-0913-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System recall (Z-0914-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System recall (Z-0927-2019)Philips Medical Systems Nederlands2019-02-22
Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System recall (Z-0928-2019)Philips Medical Systems Nederlands2019-02-22