Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Electric Co. — Predicate Candidate Screening
254 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
159 days90th percentile
254clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103489 | GE VEO RECONSTRUCTION OPTION | General Electric Co. | 2011-09-09 | 287 | 0 |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | General Electric Co. | 2008-09-26 | 44 | 0 |
| K081921 | GE VIVID E9 ULTRASOUND | General Electric Co. | 2008-08-06 | 30 | 0 |
| K073297 | GE LOGIQ P6 | General Electric Co. | 2007-12-18 | 25 | 2 |
| K072952 | GE ECHOPAC | General Electric Co. | 2007-11-16 | 29 | 0 |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUN | General Electric Co. | 2007-10-17 | 16 | 0 |
| K072075 | MODIFICATION TO GE LOGIQ A3 | General Electric Co. | 2007-08-29 | 30 | 0 |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | General Electric Co. | 2007-08-17 | 29 | 2 |
| K063006 | GE LOGIQ WORKS | General Electric Co. | 2006-11-02 | 31 | 0 |
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM | General Electric Co. | 2006-07-12 | 27 | 3 |
| K061525 | GE VIVID - I | General Electric Co. | 2006-07-03 | 31 | 1 |
| K061129 | GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 | General Electric Co. | 2006-06-01 | 38 | 0 |
| K060993 | GE LOGIQ P5 AND A5 | General Electric Co. | 2006-05-03 | 22 | 0 |
| K060542 | GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX | General Electric Co. | 2006-03-31 | 30 | 0 |
| K053435 | GE VOLUSON I | General Electric Co. | 2005-12-16 | 7 | 0 |
| K052441 | GE LOGIQ 7 ULTRASOUND BT05 | General Electric Co. | 2005-09-21 | 15 | 0 |
| K050943 | GE VIEWPOINT | General Electric Co. | 2005-05-23 | 39 | 1 |
| K050704 | MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGIN | General Electric Co. | 2005-04-08 | 21 | 2 |
| K050126 | GE LOGIQ TWIN | General Electric Co. | 2005-02-02 | 14 | 0 |
| K043112 | GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM | General Electric Co. | 2004-11-24 | 14 | 1 |
| K042257 | DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTO | General Electric Co. | 2004-09-08 | 19 | 1 |
| K041922 | GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR | General Electric Co. | 2004-07-28 | 12 | 0 |
| K041688 | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 | General Electric Co. | 2004-07-08 | 16 | 1 |
| K041552 | GE VIVID 7 BT04 | General Electric Co. | 2004-07-02 | 23 | 0 |
| K040444 | GE SIGNA 3.0T WITH EXCITE MR SYSTEM | General Electric Co. | 2004-04-14 | 85 | 6 |
| K033867 | GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS | General Electric Co. | 2003-12-19 | 7 | 0 |
| K033504 | GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM | General Electric Co. | 2003-11-25 | 20 | 1 |
| K033139 | GE MARLIN ULTRASOUND | General Electric Co. | 2003-10-23 | 23 | 1 |
| K032477 | GE LOGIQ BOOK | General Electric Co. | 2003-10-22 | 71 | 0 |
| K032974 | GE LOGIQ 5 PRO OR EXPERT | General Electric Co. | 2003-10-21 | 27 | 0 |
| K033168 | GE 0.2T SIGNA PROFILE/I MR SYSTEM | General Electric Co. | 2003-10-10 | 10 | 0 |
| K032620 | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM | General Electric Co. | 2003-10-10 | 45 | 0 |
| K032182 | GE LOGIQ 7, MODEL 2354858 | General Electric Co. | 2003-07-25 | 8 | 0 |
| K031663 | GE VIVID 7, MODEL FC0003XX | General Electric Co. | 2003-06-09 | 11 | 0 |
| K030874 | GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM | General Electric Co. | 2003-03-28 | 8 | 5 |
| K030199 | GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM | General Electric Co. | 2003-02-11 | 21 | 0 |
| K022872 | GE ROAD WARRIOR PET CT IMAGING SYSTEM | General Electric Co. | 2002-09-12 | 14 | 0 |
| K020789 | GE VIVID 3 EXPERT; GE VIVID 3 PRO | General Electric Co. | 2002-04-04 | 24 | 0 |
| K020263 | LOGIQ 3 | General Electric Co. | 2002-02-06 | 12 | 1 |
| K014206 | LOGIQBOOK | General Electric Co. | 2002-01-16 | 26 | 1 |
| K013381 | ADVANCED LUNG ANALYSIS-1 | General Electric Co. | 2001-10-26 | 14 | 0 |
| K012568 | GE VISION NUCLEAR MEDICINE WORKSTATION | General Electric Co. | 2001-09-06 | 28 | 0 |
| K012560 | GE LOGIQ A100 MP, MODEL 2272413 | General Electric Co. | 2001-08-23 | 15 | 0 |
| K010329 | LOGIQ 500 | General Electric Co. | 2001-03-01 | 27 | 0 |
| K010042 | CT PERFUSION 2 | General Electric Co. | 2001-01-30 | 25 | 0 |
| K993069 | GE DIASONICS GATEWAY AND GATEWAY FX | General Electric Co. | 1999-09-22 | 9 | 0 |
| K991611 | GE LOGIQ 500 | General Electric Co. | 1999-06-09 | 30 | 0 |
| K982004 | CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR A | General Electric Co. | 1998-08-18 | 71 | 0 |
| K980176 | HISPEED QX/I CT SCANNER SYSTEM | General Electric Co. | 1998-04-13 | 83 | 0 |
| K980169 | HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYST | General Electric Co. | 1998-04-13 | 87 | 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