Atlas FDA

Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist

FDA 510(k) clearance K163331 · decided 2017-03-17

Clearance details

K-number
K163331
Device name
Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist
Applicant
Ge Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2016-11-28
Decision date
2017-03-17
Days to decision
109 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Signa Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2299-2025)GE Medical Systems, LLC2025-08-13
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2301-2025)GE Medical Systems, LLC2025-08-13
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2302-2025)GE Medical Systems, LLC2025-08-13
GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-2303-2025)GE Medical Systems, LLC2025-08-13
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System recall (Z-2306-2025)GE Medical Systems, LLC2025-08-13
SIGNA Architect recall (Z-2130-2025)GE Medical Systems, LLC2025-07-18
Discovery MR750w 3.0T, whole body magnetic resonance scanner recall (Z-0517-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect, Nuclear Magnetic Resonance Imaging System recall (Z-0518-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System recall (Z-0519-2025)GE Medical Systems, LLC2024-11-22
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28 recall (Z-2459-2024)GE Medical Systems, LLC2024-08-02
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to D recall (Z-2464-2024)GE Medical Systems, LLC2024-08-02
Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to recall (Z-2465-2024)GE Medical Systems, LLC2024-08-02
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuc recall (Z-2467-2024)GE Medical Systems, LLC2024-08-02
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29. recall (Z-2468-2024)GE Medical Systems, LLC2024-08-02
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR3 recall (Z-2469-2024)GE Medical Systems, LLC2024-08-02
SIGNA Architect nuclear magnetic resonance imaging system recall (Z-0133-2022)GE Healthcare, LLC2021-10-16
Discovery MR750w 3.0T nuclear magnetic resonance imaging system recall (Z-0135-2022)GE Healthcare, LLC2021-10-16
Discovery MR750 3.0T nuclear magnetic resonance imaging system recall (Z-0136-2022)GE Healthcare, LLC2021-10-16
SIGNA Artist nuclear magnetic resonance imaging system recall (Z-0139-2022)GE Healthcare, LLC2021-10-16
Optima MR450w 1.5T nuclear magnetic resonance imaging system recall (Z-0140-2022)GE Healthcare, LLC2021-10-16
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to su recall (Z-2053-2021)GE Healthcare, LLC2021-07-12
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed recall (Z-2055-2021)GE Healthcare, LLC2021-07-12
Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed recall (Z-2056-2021)GE Healthcare, LLC2021-07-12
SIGNA Artist, Nuclear Magnetic Resonance Imaging System recall (Z-2061-2021)GE Healthcare, LLC2021-07-12
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2063-2021)GE Healthcare, LLC2021-07-12
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System recall (Z-2064-2021)GE Healthcare, LLC2021-07-12
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body recall (Z-0875-2020)GE Healthcare, LLC2020-01-28