Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GE Medical Systems — Predicate Candidate Screening
169 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
219 days90th percentile
169clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220851 | Venue | GE Medical Systems | 2022-06-27 | 96 | 0 |
| K220848 | Venue Fit | GE Medical Systems | 2022-06-27 | 96 | 1 |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | GE Medical Systems | 2017-11-02 | 9 | 0 |
| K103411 | IDEAL IQ SOFTWARE OPTION | GE Medical Systems | 2011-03-22 | 120 | 0 |
| K073138 | CARDIQ EXPRESS VERSION 2.0 | GE Medical Systems | 2008-02-26 | 111 | 0 |
| K053009 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | GE Medical Systems | 2005-11-17 | 22 | 3 |
| K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | GE Medical Systems | 2005-09-27 | 21 | 8 |
| K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION | GE Medical Systems | 2005-07-18 | 25 | 3 |
| K051449 | GE VIVID 7 WITH OR WITHOUT SUFFIX | GE Medical Systems | 2005-06-16 | 14 | 0 |
| K050559 | GE DISCOVERY VCT SYSTEM | GE Medical Systems | 2005-03-17 | 14 | 1 |
| K042694 | ADVANCED LUNG ANALYSIS II | GE Medical Systems | 2004-11-18 | 49 | 0 |
| K041220 | GE DISCOVERY ST SYSTEM | GE Medical Systems | 2004-06-15 | 36 | 0 |
| K040172 | MODIFICATION TO GE DISCOVERY LS SYSTEM | GE Medical Systems | 2004-04-07 | 72 | 2 |
| K031637 | INNOVA 3100 | GE Medical Systems | 2003-08-22 | 87 | 25 |
| K032045 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | GE Medical Systems | 2003-07-30 | 28 | 0 |
| K031927 | GE DELTA SOFTWARE OPTION FOR MRI | GE Medical Systems | 2003-07-02 | 9 | 0 |
| K031396 | ADVANTAGE WORKSTATION PASTING 1.1 | GE Medical Systems | 2003-05-13 | 11 | 0 |
| K031261 | CARD EP | GE Medical Systems | 2003-05-06 | 15 | 0 |
| K031230 | GE PROPELLER IMAGING OPTION FOR MRI | GE Medical Systems | 2003-05-02 | 14 | 0 |
| K030420 | LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM | GE Medical Systems | 2003-03-10 | 28 | 3 |
| K023988 | GE DISCOVERY LS SYSTEM | GE Medical Systems | 2003-02-04 | 64 | 1 |
| K023557 | CENTRICITY PACS PLUS | GE Medical Systems | 2002-11-07 | 15 | 0 |
| K023442 | EXTRA LARGE BODY COIL | GE Medical Systems | 2002-11-05 | 21 | 0 |
| K023332 | LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW | GE Medical Systems | 2002-10-23 | 16 | 0 |
| K022919 | SMART BREATH RESPIRATORY COMPENSATION OPTION | GE Medical Systems | 2002-09-19 | 15 | 0 |
| K022669 | 8 CHANNEL CARDIAC PHASED ARRAY COIL | GE Medical Systems | 2002-09-06 | 25 | 0 |
| K022397 | SIGNA 3.0T MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2002-08-22 | 30 | 0 |
| K021016 | AMX-4 PLUS MOBILE X-RAY SYSTEM | GE Medical Systems | 2002-06-17 | 80 | 0 |
| K020929 | SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 | GE Medical Systems | 2002-04-03 | 12 | 0 |
| K020796 | CARD IQ ANALYSIS II | GE Medical Systems | 2002-03-26 | 14 | 0 |
| K020483 | ADVANTAGE WORKSTATION 4.1 | GE Medical Systems | 2002-02-28 | 15 | 2 |
| K013636 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY | GE Medical Systems | 2002-01-24 | 80 | 7 |
| K014097 | GE LOGIQ 5 | GE Medical Systems | 2002-01-10 | 29 | 1 |
| K012875 | SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-11-20 | 85 | 0 |
| K013561 | LIGHTSPEED 4.0 CT SCANNER SYSTEM | GE Medical Systems | 2001-11-08 | 13 | 4 |
| K013481 | DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION | GE Medical Systems | 2001-11-02 | 14 | 0 |
| K013422 | CARDIQ FUNCTION | GE Medical Systems | 2001-10-30 | 15 | 0 |
| K012970 | GE SIGNA ASSET IMAGING OPTION | GE Medical Systems | 2001-09-24 | 20 | 0 |
| K012775 | GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER | GE Medical Systems | 2001-09-18 | 29 | 0 |
| K012836 | MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM | GE Medical Systems | 2001-09-07 | 15 | 0 |
| K012200 | 1.5T INFINITY TWINSPEED MR SYSTEM | GE Medical Systems | 2001-08-03 | 21 | 4 |
| K011624 | EXPEDIO 500D R&F X-RAY SYSTEM | GE Medical Systems | 2001-06-08 | 14 | 11 |
| K011188 | GE LOGIQ 9, MODEL 2188900-X | GE Medical Systems | 2001-05-18 | 30 | 0 |
| K002997 | FIESTA IMAGING OPTION | GE Medical Systems | 2001-04-11 | 197 | 0 |
| K003613 | 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL | GE Medical Systems | 2001-04-03 | 132 | 0 |
| K003947 | FUNCTIONAL BRAIN MAPPING OPTION FOR MRI | GE Medical Systems | 2001-03-13 | 82 | 0 |
| K003946 | SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL | GE Medical Systems | 2001-02-27 | 68 | 0 |
| K003575 | MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2001-01-17 | 58 | 0 |
| K003408 | CT CORD IQ OPTION 1.0 | GE Medical Systems | 2000-11-17 | 15 | 0 |
| K002611 | SIGNA MFO/I MAGNETIC RESONANCE SYSTEM | GE Medical Systems | 2000-10-31 | 70 | 2 |
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