Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical Systems, LLC — Predicate Candidate Screening
105 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
193 days90th percentile
105clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 | 219 | 0 |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorit | Ge Medical Systems, LLC | 2026-04-14 | 166 | 0 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 | 128 | 0 |
| K253780 | SIGNA™ Bolt | Ge Medical Systems, LLC | 2026-02-06 | 72 | 0 |
| K253779 | SIGNA™ Sprint Select | Ge Medical Systems, LLC | 2026-02-05 | 71 | 0 |
| K252379 | AIR Recon DL | Ge Medical Systems, LLC | 2025-12-23 | 146 | 0 |
| K251399 | SIGNA™ Sprint | Ge Medical Systems, LLC | 2025-09-11 | 128 | 0 |
| K250941 | Revolution Vibe | Ge Medical Systems, LLC | 2025-08-01 | 126 | 0 |
| K243667 | Sonic DL | Ge Medical Systems, LLC | 2025-06-05 | 190 | 0 |
| K250379 | SIGNA Prime Elite | Ge Medical Systems, LLC | 2025-03-17 | 34 | 0 |
| K241242 | SIGNA MAGNUS | Ge Medical Systems, LLC | 2024-10-17 | 167 | 0 |
| K233750 | ECG-less Cardiac | Ge Medical Systems, LLC | 2024-04-02 | 132 | 0 |
| K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm | Ge Medical Systems, LLC | 2023-05-25 | 185 | 0 |
| K230082 | Auto Segmentation | Ge Medical Systems, LLC | 2023-05-04 | 113 | 0 |
| K223514 | Spectral Bone Marrow | Ge Medical Systems, LLC | 2023-03-09 | 107 | 0 |
| K213999 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2022-02-18 | 59 | 0 |
| K213709 | SIGNA PET/MR | Ge Medical Systems, LLC | 2022-01-20 | 57 | 3 |
| K213715 | Revolution Apex, Revolution Apex Elite, Revolution Apex Plus | Ge Medical Systems, LLC | 2021-12-17 | 23 | 11 |
| K211161 | Critical Care Suite with Endotracheal Tube Positing AI algor | Ge Medical Systems, LLC | 2021-10-29 | 193 | 0 |
| K211846 | Discovery MI Gen2 | Ge Medical Systems, LLC | 2021-08-20 | 66 | 0 |
| K211118 | SIGNA 7.0T | Ge Medical Systems, LLC | 2021-05-13 | 28 | 1 |
| K210982 | AMX Navigate | Ge Medical Systems, LLC | 2021-04-28 | 27 | 1 |
| K203617 | MaxFOV 2 | Ge Medical Systems, LLC | 2021-03-02 | 81 | 0 |
| K201745 | Deep Learning Image Reconstruction for Gemstone Spectral Ima | Ge Medical Systems, LLC | 2020-12-10 | 167 | 0 |
| K201615 | SIGNA 7.0T | Ge Medical Systems, LLC | 2020-10-15 | 122 | 1 |
| K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019-08-12 | 266 | 0 |
| K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution | Ge Medical Systems, LLC | 2019-07-26 | 24 | 11 |
| K183202 | Deep Learning Image Reconstruction | Ge Medical Systems, LLC | 2019-04-12 | 144 | 0 |
| K183161 | SnapShot Freeze 2 | Ge Medical Systems, LLC | 2019-02-13 | 90 | 0 |
| K183231 | SIGNA Premier | Ge Medical Systems, LLC | 2019-01-18 | 59 | 5 |
| K182234 | Optima XR240amx | Ge Medical Systems, LLC | 2018-09-06 | 20 | 2 |
| K180318 | PET Digital Gating | Ge Medical Systems, LLC | 2018-04-11 | 65 | 0 |
| K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | 2018-01-12 | 52 | 2 |
| K171128 | SIGNA Premier | Ge Medical Systems, LLC | 2017-07-14 | 88 | 6 |
| K162722 | HyperSense | Ge Medical Systems, LLC | 2017-04-20 | 203 | 0 |
| K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 | Ge Medical Systems, LLC | 2017-03-17 | 109 | 27 |
| K163619 | SIGNA PET/MR | Ge Medical Systems, LLC | 2017-02-14 | 54 | 5 |
| K163213 | Revolution CT | Ge Medical Systems, LLC | 2016-12-16 | 30 | 10 |
| K162403 | HyperBand | Ge Medical Systems, LLC | 2016-11-18 | 81 | 0 |
| K162990 | Optima XR240amx | Ge Medical Systems, LLC | 2016-11-15 | 19 | 2 |
| K161397 | MAGiC | Ge Medical Systems, LLC | 2016-08-31 | 104 | 0 |
| K161574 | Discovery MI | Ge Medical Systems, LLC | 2016-08-11 | 65 | 1 |
| K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w | Ge Medical Systems, LLC | 2016-06-09 | 98 | 31 |
| K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Sy | Ge Medical Systems, LLC | 2015-08-14 | 85 | 0 |
| K143368 | GenIQ | Ge Medical Systems, LLC | 2015-07-29 | 246 | 0 |
| K150193 | Customer Remote Console (CRC) | Ge Medical Systems, LLC | 2015-03-24 | 55 | 0 |
| K142361 | Discovery MR750 3.0T | Ge Medical Systems, LLC | 2014-12-05 | 102 | 2 |
| K142098 | SIGNA PET/MR | Ge Medical Systems, LLC | 2014-11-24 | 115 | 5 |
| K142085 | DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 | Ge Medical Systems, LLC | 2014-09-26 | 57 | 21 |
| K142383 | Optima XR200amx, Optima XR220amx | Ge Medical Systems, LLC | 2014-09-25 | 30 | 8 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda