Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ge Medical Systems, Inc. · Predicate Candidate Screening
54 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
88 days90th percentile
54clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091673 | GE LIGHTSPEED ACT FP16 | Ge Medical Systems, Inc. | 2009-06-24 | 15 | 0 |
| K082104 | GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LI | Ge Medical Systems, Inc. | 2008-09-02 | 39 | 0 |
| K042844 | GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SI | Ge Medical Systems, Inc. | 2004-11-03 | 19 | 0 |
| K042053 | INNOVA 4100, INNOVA 3100 | Ge Medical Systems, Inc. | 2004-08-26 | 27 | 33 |
| K040125 | SENOGRAPHIC STEREO | Ge Medical Systems, Inc. | 2004-04-19 | 90 | 0 |
| K033244 | DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH | Ge Medical Systems, Inc. | 2003-10-16 | 9 | 8 |
| K031209 | GE 1.5T 8 CHANNEL TORSO COIL | Ge Medical Systems, Inc. | 2003-05-23 | 36 | 0 |
| K023943 | CT COLONOGRAPHY | Ge Medical Systems, Inc. | 2003-05-06 | 161 | 0 |
| K030934 | GE LOGIQ 9 MODEL 2375600 | Ge Medical Systems, Inc. | 2003-04-17 | 23 | 0 |
| K030953 | GE 3.0T GENERAL PURPOSE FLEX COIL | Ge Medical Systems, Inc. | 2003-04-10 | 14 | 0 |
| K030495 | 3.0T TORSO PHASED ARRAY COIL | Ge Medical Systems, Inc. | 2003-03-05 | 14 | 0 |
| K024200 | INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) | Ge Medical Systems, Inc. | 2003-01-16 | 27 | 7 |
| K024137 | JUPITER PROCESSING AND REVIEW WORKSTATION | Ge Medical Systems, Inc. | 2003-01-15 | 30 | 2 |
| K023178 | INNOVA 4100 | Ge Medical Systems, Inc. | 2002-11-26 | 64 | 25 |
| K022322 | INNOVA AND INNOVA 2000 S | Ge Medical Systems, Inc. | 2002-10-08 | 83 | 5 |
| K022240 | MOBILE MILLENNIUM MG SYSTEM | Ge Medical Systems, Inc. | 2002-08-06 | 26 | 0 |
| K022310 | ADVANTAGE WINDOWS X-RAY/MR FUSION | Ge Medical Systems, Inc. | 2002-08-01 | 15 | 0 |
| K021491 | HISPEED DUAL | Ge Medical Systems, Inc. | 2002-05-22 | 13 | 2 |
| K011604 | PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTI | Ge Medical Systems, Inc. | 2001-08-22 | 90 | 0 |
| K012385 | HISPEED X/I SMART GANTRY OPTION | Ge Medical Systems, Inc. | 2001-08-10 | 14 | 0 |
| K012389 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM | Ge Medical Systems, Inc. | 2001-08-10 | 14 | 4 |
| K012313 | CT COLONOGRAPHY/NAVIGATOR2 | Ge Medical Systems, Inc. | 2001-08-07 | 15 | 1 |
| K010641 | GE CT-PET SYSTEM | Ge Medical Systems, Inc. | 2001-03-30 | 25 | 0 |
| K010336 | ADVANTAGE WINDOWS CT/PET FUSION | Ge Medical Systems, Inc. | 2001-02-16 | 11 | 2 |
| K003573 | DIFFUSION TENSOR IMAGING OPTION | Ge Medical Systems, Inc. | 2001-01-23 | 64 | 0 |
| K003931 | VIVID 7 WITH SONOPAC, MODEL FB0008XX | Ge Medical Systems, Inc. | 2001-01-18 | 29 | 0 |
| K003849 | GE ADVANCE NXI PET SYSTEM | Ge Medical Systems, Inc. | 2000-12-22 | 10 | 0 |
| K001946 | NEUROVASCULAR ARRAY COIL | Ge Medical Systems, Inc. | 2000-08-30 | 65 | 0 |
| K001267 | GE SYSTEM FIVE | Ge Medical Systems, Inc. | 2000-05-12 | 22 | 0 |
| K000516 | GE LOGIQ 700 | Ge Medical Systems, Inc. | 2000-04-19 | 63 | 0 |
| K000695 | GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED D | Ge Medical Systems, Inc. | 2000-03-16 | 15 | 0 |
| K000300 | LIGHTSPEED 2.0CT SCANNER SYSTEM | Ge Medical Systems, Inc. | 2000-02-15 | 15 | 0 |
| K993037 | LCV+ VERSION 2 | Ge Medical Systems, Inc. | 2000-02-14 | 158 | 6 |
| K993645 | CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM | Ge Medical Systems, Inc. | 1999-12-21 | 54 | 2 |
| K993791 | CT PERFUSION OPTION | Ge Medical Systems, Inc. | 1999-11-24 | 15 | 0 |
| K993792 | SMART VESSEL ANALYSIS (SMART VA) OPTION | Ge Medical Systems, Inc. | 1999-11-24 | 15 | 0 |
| K993665 | LEGEND CRF FLUORO AND RAD SYSTEM | Ge Medical Systems, Inc. | 1999-11-12 | 14 | 0 |
| K992746 | SIGNA HFO/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-11-09 | 85 | 0 |
| K993364 | GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION | Ge Medical Systems, Inc. | 1999-11-05 | 30 | 0 |
| K993365 | GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION | Ge Medical Systems, Inc. | 1999-11-05 | 30 | 0 |
| K993090 | SILHOUETTE FC | Ge Medical Systems, Inc. | 1999-10-01 | 15 | 13 |
| K992135 | SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-09-08 | 76 | 0 |
| K991629 | GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND G | Ge Medical Systems, Inc. | 1999-08-02 | 83 | 0 |
| K992208 | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM | Ge Medical Systems, Inc. | 1999-07-12 | 12 | 0 |
| K991716 | HISPEED NX/I CT SCANNER SYSTEM | Ge Medical Systems, Inc. | 1999-06-18 | 29 | 2 |
| K990550 | 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM | Ge Medical Systems, Inc. | 1999-05-11 | 78 | 0 |
| K990226 | GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW | Ge Medical Systems, Inc. | 1999-02-09 | 15 | 0 |
| K982772 | SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY | Ge Medical Systems, Inc. | 1998-10-15 | 69 | 0 |
| K973270 | LEG'MAP OPTION | Ge Medical Systems, Inc. | 1997-11-25 | 84 | 0 |
| K973368 | STRAIT'MAP OPTION | Ge Medical Systems, Inc. | 1997-10-17 | 39 | 0 |
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