Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
General Electric Medical Systems Information Techn — Predicate Candidate Screening
33 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
190 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023380 | T-WAVE ALTERMANS (TWA) ALGORITHM OPTION | General Electric Medical Systems Information Techn | 2002-12-03 | 56 | 0 |
| K021470 | SEER LIGHT COMPACT DIGITAL HOLTER RECORDER | General Electric Medical Systems Information Techn | 2002-11-14 | 190 | 0 |
| K023100 | ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS | General Electric Medical Systems Information Techn | 2002-10-11 | 23 | 0 |
| K021454 | UNITY NETWORK ID | General Electric Medical Systems Information Techn | 2002-10-01 | 148 | 0 |
| K020290 | DASH 3000/4000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 2002-08-14 | 198 | 0 |
| K021366 | MAC-LAB/CARDIOLAB EP/COMBOLAB | General Electric Medical Systems Information Techn | 2002-07-03 | 64 | 1 |
| K020661 | UNITY IS PATIENT VIEWER | General Electric Medical Systems Information Techn | 2002-05-24 | 84 | 0 |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM | General Electric Medical Systems Information Techn | 2002-05-07 | 11 | 1 |
| K020524 | PATIENTNET MONITORING SYSTEM | General Electric Medical Systems Information Techn | 2002-03-20 | 29 | 1 |
| K012467 | SOLAR 8000M SYSTEM | General Electric Medical Systems Information Techn | 2002-02-11 | 194 | 1 |
| K014108 | MAC 5000 ECG ANALYSIS SYSTEM | General Electric Medical Systems Information Techn | 2002-01-10 | 28 | 0 |
| K012466 | BIS/EEG MODULE | General Electric Medical Systems Information Techn | 2001-10-01 | 61 | 0 |
| K011000 | TRAM 2001 MODULE | General Electric Medical Systems Information Techn | 2001-06-29 | 87 | 1 |
| K010164 | ICG MODULE | General Electric Medical Systems Information Techn | 2001-04-09 | 81 | 0 |
| K002957 | SOLAR SPO2 MODULE WITH MASIMO SET | General Electric Medical Systems Information Techn | 2000-10-18 | 26 | 0 |
| K002209 | GE MARQUETTE ECG ANALYSIS PROGRAM | General Electric Medical Systems Information Techn | 2000-08-18 | 28 | 0 |
| K001359 | DASH 3000/4000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 2000-07-18 | 81 | 0 |
| K001268 | GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS | General Electric Medical Systems Information Techn | 2000-07-17 | 88 | 0 |
| K001305 | MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM | General Electric Medical Systems Information Techn | 2000-06-27 | 64 | 0 |
| K001112 | GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC | General Electric Medical Systems Information Techn | 2000-06-14 | 69 | 0 |
| K000645 | GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, V | General Electric Medical Systems Information Techn | 2000-05-24 | 89 | 0 |
| K000779 | APEXPRO TELEMETRY SYSTEM | General Electric Medical Systems Information Techn | 2000-05-18 | 69 | 1 |
| K994430 | IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM | General Electric Medical Systems Information Techn | 2000-03-28 | 90 | 0 |
| K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | 2000-03-23 | 139 | 0 |
| K992948 | MAC-LAB SYSTEM | General Electric Medical Systems Information Techn | 1999-11-29 | 90 | 0 |
| K992929 | DASH 3000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 1999-11-26 | 87 | 1 |
| K991786 | MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPT | General Electric Medical Systems Information Techn | 1999-11-18 | 177 | 0 |
| K992637 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | General Electric Medical Systems Information Techn | 1999-11-03 | 89 | 1 |
| K991014 | CASE 8000 EXERCISE TESTING SYSTEM | General Electric Medical Systems Information Techn | 1999-10-20 | 208 | 0 |
| K991905 | COROMETRICS MODEL 171 AND 172 FETAL MONITOR | General Electric Medical Systems Information Techn | 1999-09-01 | 89 | 0 |
| K991735 | MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, M | General Electric Medical Systems Information Techn | 1999-08-19 | 90 | 0 |
| K991739 | COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR | General Electric Medical Systems Information Techn | 1999-08-19 | 90 | 0 |
| K990068 | SOLAR 9500 INFORMATION MONITOR | General Electric Medical Systems Information Techn | 1999-07-14 | 187 | 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