Medical device manufacturer
General Electric Company
General Electric Company holds 256 FDA 510(k) clearances across 54 product codes. Median elapsed review time is 43 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 256
- Product codes
- 54
- Median review
- 43 days
- Recall records
- 0
How does FDA spell General Electric Company?
FDA publishes this company under 2 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| General Electric Co. | device/510k | normalised |
| General Electric Company | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does General Electric Company file in?
54 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 31 | 67 days | |
| LNH | System, Nuclear Magnetic Resonance Imaging | 29 | 90 days | |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 23 | 25 days | |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 21 | 84 days | |
| IYX | Camera, Scintillation (Gamma) | 15 | 32 days | |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 12 | 48 days | |
| ITX | Transducer, Ultrasonic, Diagnostic | 11 | 112 days | |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 10 | 35 days | |
| KPS | System, Tomography, Computed, Emission | 9 | 43 days | |
| KPR | System, X-Ray, Stationary | 5 | 28 days | |
| LLZ | System, Image Processing, Radiological | 5 | 31 days | |
| DSI | Detector And Alarm, Arrhythmia | 4 | 23 days | |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 4 | 59 days | |
| IZI | System, X-Ray, Angiographic | 4 | 35 days | |
| IXR | Table, Radiographic, Tilting | 3 | 18 days | |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 3 | 27 days | |
| JWM | System, Tomographic, Nuclear | 3 | 36 days | |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 | 64 days | |
| EAP | Unit, X-Ray, Intraoral | 2 | 27 days | |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 33 days | |
| GDF | Guide, Needle, Surgical | 2 | 14 days | |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 2 | 36 days | |
| IYB | Tube Mount, X-Ray, Diagnostic | 2 | 73 days | |
| IYE | Accelerator, Linear, Medical | 2 | 66 days | |
| IZH | System, X-Ray, Mammographic | 2 | 21 days |
Showing the 25 they file in most, of 54.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has General Electric Company had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has General Electric Company cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | MUE | 275 | |
| K103485 | SENOGRAPH DS, SENOGRAPH ESSENSTIAL | MUE | 314 | |
| K103489 | GE VEO RECONSTRUCTION OPTION | JAK | 287 | |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | KGI | 44 | |
| K081921 | GE VIVID E9 ULTRASOUND | IYN | 30 | |
| K073297 | GE LOGIQ P6 | IYN | 25 | |
| K072952 | GE ECHOPAC | LLZ | 29 | |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | IYO | 16 | |
| K072075 | MODIFICATION TO GE LOGIQ A3 | IYN | 30 | |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | IYN | 29 |
Source: openFDA device/510k · retrieved
Watch what General Electric Company files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.