Company · US
GE Medical Systems, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.
329510(k) clearances (7 in 12 months)
235recalls (23 in 12 months)
200recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 162 |
| JAK | System, X-Ray, Tomography, Computed | 97 |
| KPS | System, Tomography, Computed, Emission | 40 |
| LLZ | System, Image Processing, Radiological | 24 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 23 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 21 |
| OWB | Interventional Fluoroscopic X-Ray System | 21 |
| MOS | Coil, Magnetic Resonance, Specialty | 20 |
| IZL | System, X-Ray, Mobile | 18 |
| KPR | System, X-Ray, Stationary | 18 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 13 |
| IZI | System, X-Ray, Angiographic | 13 |
| BSZ | Gas-Machine, Anesthesia | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 5 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 5 |
| MMP | Cover, Barrier, Protective | 5 |
| FRG | Wrap, Sterilization | 4 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 4 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 4 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2026 | K253808 | AIR Recon DL GE Medical Systems | LNH |
| Jun 24, 2026 | K253560 | Enhanced Boundary for PCCT Ge Medical Systems, LLC | JAK |
| Apr 14, 2026 | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm Ge Medical Systems, LLC | QIH |
| Mar 20, 2026 | K253520 | Photonova Spectra, Photonova Spectra Select Ge Medical Systems, LLC | JAK |
| Feb 6, 2026 | K253780 | SIGNA Bolt Ge Medical Systems, LLC | LNH |
| Feb 5, 2026 | K253779 | SIGNA Sprint Select Ge Medical Systems, LLC | LNH |
| Dec 23, 2025 | K252379 | AIR Recon DL Ge Medical Systems, LLC | LNH |
| Sep 11, 2025 | K251399 | SIGNA Sprint Ge Medical Systems, LLC | LNH |
| Aug 1, 2025 | K250941 | Revolution Vibe Ge Medical Systems, LLC | JAK |
| Jun 5, 2025 | K243667 | Sonic DL Ge Medical Systems, LLC | LNH |
| Mar 17, 2025 | K250379 | SIGNA Prime Elite Ge Medical Systems, LLC | LNH |
| Oct 17, 2024 | K241242 | SIGNA MAGNUS Ge Medical Systems, LLC | LNH |
| Apr 2, 2024 | K233750 | ECG-less Cardiac Ge Medical Systems, LLC | JAK |
| May 25, 2023 | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite Ge Medical Systems, LLC | QBS |
| May 4, 2023 | K230082 | Auto Segmentation Ge Medical Systems, LLC | QKB |
| Mar 9, 2023 | K223514 | Spectral Bone Marrow Ge Medical Systems, LLC | JAK |
| Jun 27, 2022 | K220851 | Venue GE Medical Systems | IYN |
| Jun 27, 2022 | K220848 | Venue Fit GE Medical Systems | IYN |
| Feb 18, 2022 | K213999 | Deep Learning Image Reconstruction Ge Medical Systems, LLC | JAK |
| Jan 20, 2022 | K213709 | SIGNA PET/MR Ge Medical Systems, LLC | OUO |
| Dec 17, 2021 | K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re Ge Medical Systems, LLC | JAK |
| Oct 29, 2021 | K211161 | Critical Care Suite with Endotracheal Tube Positing AI algorithm Ge Medical Systems, LLC | QIH |
| Aug 20, 2021 | K211846 | Discovery MI Gen2 Ge Medical Systems, LLC | KPS |
| May 13, 2021 | K211118 | SIGNA 7.0T Ge Medical Systems, LLC | LNH |
| Apr 28, 2021 | K210982 | AMX Navigate Ge Medical Systems, LLC | IZL |
| Mar 2, 2021 | K203617 | MaxFOV 2 Ge Medical Systems, LLC | JAK |
| Dec 10, 2020 | K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Imaging Ge Medical Systems, LLC | JAK |
| Oct 15, 2020 | K201615 | SIGNA 7.0T Ge Medical Systems, LLC | LNH |
| Aug 12, 2019 | K183182 | Critical Care Suite Ge Medical Systems, LLC | QFM |
| Jul 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Ge Medical Systems, LLC | JAK |
| Apr 12, 2019 | K183202 | Deep Learning Image Reconstruction Ge Medical Systems, LLC | JAK |
| Feb 13, 2019 | K183161 | SnapShot Freeze 2 Ge Medical Systems, LLC | JAK |
| Jan 18, 2019 | K183231 | SIGNA Premier Ge Medical Systems, LLC | LNH |
| Sep 6, 2018 | K182234 | Optima XR240amx Ge Medical Systems, LLC | IZL |
| Apr 11, 2018 | K180318 | PET Digital Gating Ge Medical Systems, LLC | KPS |
| Jan 12, 2018 | K173602 | Optima XR240amx, AutoGrid Ge Medical Systems, LLC | IZL |
| Nov 2, 2017 | K173341 | Vivid E80, Vivid E90, Vivid E95 GE Medical Systems | IYN |
| Jul 14, 2017 | K171128 | SIGNA Premier Ge Medical Systems, LLC | LNH |
| Apr 20, 2017 | K162722 | HyperSense Ge Medical Systems, LLC | LNH |
| Mar 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artis Ge Medical Systems, LLC | LNH |
| Feb 14, 2017 | K163619 | SIGNA PET/MR Ge Medical Systems, LLC | OUO |
| Dec 16, 2016 | K163213 | Revolution CT Ge Medical Systems, LLC | JAK |
| Nov 18, 2016 | K162403 | HyperBand Ge Medical Systems, LLC | LNH |
| Nov 15, 2016 | K162990 | Optima XR240amx Ge Medical Systems, LLC | IZL |
| Aug 31, 2016 | K161397 | MAGiC Ge Medical Systems, LLC | LNH |
| Aug 11, 2016 | K161574 | Discovery MI Ge Medical Systems, LLC | KPS |
| Jun 9, 2016 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T Ge Medical Systems, LLC | LNH |
| Aug 14, 2015 | K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems Ge Medical Systems, LLC | JAK |
| Jul 29, 2015 | K143368 | GenIQ Ge Medical Systems, LLC | LLZ |
| Mar 24, 2015 | K150193 | Customer Remote Console (CRC) Ge Medical Systems, LLC | LLZ |
Newest 50 of 329.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR240amx, Mobile Digital Radiographic System Open, Classified |
IZL | K162990 K173602 +1 |
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR220amx, Mobile Digital-Ready Radiographic System Open, Classified |
IZL | K103476 K142383 |
| Jul 13, 2026 | GE Medical Systems, LLC Optima XR200amx, Mobile Digital-Ready Radiographic System Open, Classified |
IZL | K103476 K142383 |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 Open, Classified |
FMZ | K020543 K101788 +2 |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX Open, Classified |
FMZ | K152814 K213551 |
| Jun 17, 2026 | GE Medical Systems, LLC Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models Open, Classified |
FMZ | K020543 K101788 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia Moveo angiographic X-ray system Open, Classified |
OWB | K251199 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 7 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 5 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| Jun 5, 2026 | GE Medical Systems, LLC Allia IGS 3 Pulse angiographic X-ray system Open, Classified |
OWB | K232344 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 Open, Classified |
JAK | K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 Open, Classified |
JAK | K163213 K191777 +1 |
| May 8, 2026 | GE Medical Systems, LLC Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 Open, Classified |
JAK | K163213 K191777 +1 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 Open, Classified |
JAK | K191777 K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 Open, Classified |
JAK | K213715 |
| May 8, 2026 | GE Medical Systems, LLC Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 Open, Classified |
JAK | K133705 K163213 +2 |
| May 8, 2026 | GE Medical Systems, LLC Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 Open, Classified |
JAK | K213938 |
| Mar 20, 2026 | GE Medical Systems, LLC Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP Open, Classified |
JAK | K162314 |
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-02 Open, Classified |
LLZ | K123174 |
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2 Open, Classified |
LLZ | K150420 |
| Mar 16, 2026 | GE Medical Systems, LLC Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 58 Open, Classified |
LLZ | K182419 |
| Dec 9, 2025 | GE Medical Systems, LLC Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography Open, Classified |
MUE | K162268 K173576 +1 |
| Oct 22, 2025 | GE Medical Systems, LLC MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4 Open, Classified |
DPS | K173830 |
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533 Open, Classified |
IYN | K214039 |
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535 Open, Classified |
IYN | K214039 |
| Oct 15, 2025 | GE Medical Systems, LLC LOGIQ P10 series with software version R4.5.7 Model Number
5877534 Open, Classified |
IYN | K214039 |
| Aug 22, 2025 | GE Medical Systems, LLC GE HealthCare OEC 9900 Elite C-arm Systems. Open, Classified |
OWB | K073543 K082781 +2 |
| Aug 22, 2025 | GE Medical Systems, LLC GE HealthCare OEC 9800. Open, Classified |
OWB | K021049 K111551 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K213603 |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance Open, Classified |
LNH | K142098 K163619 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K213668 |
| Aug 13, 2025 | GE Medical Systems, LLC GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | None listed |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K171128 K183231 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K160618 K163331 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K132376 K142085 +2 |
| Aug 13, 2025 | GE Medical Systems, LLC GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K142085 K160618 +1 |
| Aug 13, 2025 | GE Medical Systems, LLC GE Signa Voyager, Nuclear Magnetic Resonance Imaging System Open, Classified |
LNH | K161567 K192426 |
Newest 50 of 235.