65 devices · 62 companies · 2018
AI-enabled medical devices FDA authorized in 2018
65 devices authorized in 2018, 2018, from 62 companies across 36 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (61 of 65 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2018
- LLZ · System, Image Processing, Radiological21
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic4
- QAS · Radiological Computer-Assisted Triage And Notification Software3
- QDQ · Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2
- DQK · Computer, Diagnostic, Programmable2
- JAK · System, X-Ray, Tomography, Computed2
- MWI · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2
- QEA · Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid1
- POS · Physiological Signal Based Seizure Monitoring System1
- QEK · Angiographic Coronary Vascular Physiologic Simulation Software1
- DPS · Electrocardiograph1
- PJA · Coronary Vascular Physiologic Simulation Software1
- LNH · System, Nuclear Magnetic Resonance Imaging1
- PCS · Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox1
- KPS · System, Tomography, Computed, Emission1
- OMB · Automatic Event Detection Software For Full-Montage Electroencephalograph1
- POV · Semen Analysis Device1
- GKZ · Counter, Differential Cell1
- NQQ · System, Imaging, Optical Coherence Tomography (Oct)1
- GXY · Electrode, Cutaneous1
- GWN · Nystagmograph1
- DXH · Transmitters And Receivers, Electrocardiograph, Telephone1
- QCJ · Closed Loop Auto Titration Device For Oral Appliances1
- JIL · Method, Enzymatic, Glucose (Urinary, Non-Quantitative)1
- IYO · System, Imaging, Pulsed Echo, Ultrasonic1
- QKB · Radiological Image Processing Software For Radiation Therapy1
- OLO · Orthopedic Stereotaxic Instrument1
- QCC · Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals1
- NAY · System, Surgical, Computer Controlled Instrument1
- QBS · Radiological Computer Assisted Detection/Diagnosis Software For Fracture1
- OBH · Monitor, Extracellular Fluid, Lymphedema, Extremity1
- PIB · Diabetic Retinopathy Detection Device1
- JAA · System, X-Ray, Fluoroscopic, Image-Intensified1
- QAQ · Adjunctive Predictive Cardiovascular Indicator1
- OIW · Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types1
- PNN · Orthodontic Software1
Panels
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| AmCAD-UOK180867 · 510(k) | AmCad BioMed Corporation | Radiology | LLZ | database entry | |
| EyeBOXDEN170091 · De Novo | Oculogica, Inc. | Neurology | QEA | database entry | |
| Quantib NDK182564 · 510(k) | Quantib BV | Radiology | LLZ | database entry | |
| iSchemaView RAPIDK182130 · 510(k) | iSchemaView, Inc. | Radiology | LLZ | database entry | |
| vascuCAPK183012 · 510(k) | Elucid Bioimaging Inc. | Radiology | LLZ | database entry | |
| EmbraceK181861 · 510(k) | Empatica Srl | Neurology | POS | database entry | |
| FFRangio SystemK182149 · 510(k) | CathWorks Ltd | Cardiovascular | QEK | database entry | |
| Cardio-TriTest v6.5K182790 · 510(k) | Cardio-Phoenix Inc. | Cardiovascular | DPS | database entry | |
| Centricity Universal ViewerK182419 · 510(k) | GE Healthcare | Radiology | LLZ | database entry | |
| FFRctK182035 · 510(k) | HeartFlow, Inc | Cardiovascular | PJA | database entry | |
| PowerLook Tomo Detection V2 SoftwareK182373 · 510(k) | iCAD Inc. | Radiology | QDQ | database entry | |
| AMRA ProfilerK173749 · 510(k) | AMRA Medical AB | Radiology | LNH | database entry | |
| FerriSmart Analysis SystemK182218 · 510(k) | Resonance Health Analysis Services Pty Ltd | Radiology | PCS | database entry | |
| SubtlePETK182336 · 510(k) | Subtle Medical, Inc. | Radiology | KPS | database entry | |
| Persyst 14 EEG Review and Analysis SoftwareK182181 · 510(k) | Persyst Development Corporation | Neurology | OMB | database entry | |
| TransparaK181704 · 510(k) | ScreenPoint Medical BV | Radiology | QDQ | database entry | |
| Vitrea CT Brain PerfusionK181247 · 510(k) | Vital Images, Inc. | Radiology | LLZ | database entry | |
| AI-ECG PlatformK180432 · 510(k) | Shenzhen Carewell Electronics., Ltd | Cardiovascular | DQK | database entry | |
| LensHooke X1 Pro Semen Quality Analyzer, LensHooK180343 · 510(k) | Bonraybio Co., Ltd. | Hematology | POV | database entry | |
| icobrainK181939 · 510(k) | icometrix NV | Radiology | LLZ | database entry | |
| Athelas OneK181288 · 510(k) | Athelas Inc. | Hematology | GKZ | database entry | |
| NvisionVLE Imaging System, NvisionVLE Optical PrK182616 · 510(k) | NinePoint Medical, Inc. | Radiology | NQQ | database entry | |
| AccipiolxK182177 · 510(k) | MaxQ-Al Ltd. | Radiology | QAS | database entry | |
| Vivid E80, Vivid E90, Vivid E95K181685 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| Arterys MICAK182034 · 510(k) | Arterys Inc. | Radiology | LLZ | database entry | |
| Ziostation2K181892 · 510(k) | Ziosoft, Inc. | Radiology | LLZ | database entry | |
| Sense System with IBT ElectrodesK182112 · 510(k) | Infinite Biomedical Technologies, LLC | Neurology | GXY | database entry | |
| RightEye Vision SystemK181771 · 510(k) | RightEye, LLC | Neurology | GWN | database entry | |
| FibriCheckK173872 · 510(k) | Qompium nv | Cardiovascular | DXH | database entry | |
| Volpara Imaging SoftwareK182310 · 510(k) | Volpara Health Technologies Limited | Radiology | LLZ | database entry | |
| Zio AT ECG Monitoring System, ZEUS SystemK181502 · 510(k) | iRhythm Technologies, Inc. | Cardiovascular | DQK | database entry | |
| MATRx plusDEN170090 · De Novo | Zephyr Sleep Technologies | Dental | QCJ | database entry | |
| BriefCaseK180647 · 510(k) | Aidoc Medical, Ltd. | Radiology | QAS | database entry | |
| Quantitative Total Extensible ImagingK173444 · 510(k) | AIQ Solutions, Inc. | Radiology | LLZ | database entry | |
| DIP/U.S. Urine Analysis Test SystemK173327 · 510(k) | Healthy.io Ltd | Clinical Chemistry | JIL | database entry | |
| UscanK181574 · 510(k) | EchoNous, Inc. | Radiology | IYO | database entry | |
| Workflow BoxK181572 · 510(k) | Mirada Medical Ltd. | Radiology | QKB | database entry | |
| NuVasive Pulse SystemK180038 · 510(k) | NuVasive, Incorporated | Neurology | OLO | database entry | |
| DenSeeMammoK173574 · 510(k) | Statlife | Radiology | LLZ | database entry | |
| EchoMD Automated Ejection Fraction SoftwareK173780 · 510(k) | Bay Labs, Inc. | Radiology | LLZ | database entry | |
| HealthCCSK172983 · 510(k) | Zebra Medical Vision Ltd. | Radiology | JAK | database entry | |
| DreaMed Advisor ProDEN170043 · De Novo | DreaMed Diabetes, Ltd. | Clinical Chemistry | QCC | database entry | |
| LungQ SoftwareK173821 · 510(k) | Thirona Corporation | Radiology | JAK | database entry | |
| TransEnterix Senhance Surgical SystemK180163 · 510(k) | TransEnterix, Inc. | Gastroenterology-Urology | NAY | database entry | |
| OsteoDetectDEN180005 · De Novo | Imagen Technologies, Inc. | Radiology | QBS | database entry | |
| Clarius Ultrasound ScannerK180799 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| Ventripoint Medical System PlusK173810 · 510(k) | Ventripoint Diagnostics, Ltd. | Radiology | IYN | database entry | |
| VenueK180599 · 510(k) | GE Medical Systems Ultrasound and Primary Care Diagnostics, | Radiology | IYN | database entry | |
| PeraServer and PeraTrendK172959 · 510(k) | PeraHealth, Inc. | Cardiovascular | MWI | database entry | |
| Viz CTPK180161 · 510(k) | Viz.ai, Inc. | Radiology | LLZ | database entry | |
| SOZOK180126 · 510(k) | ImpediMed Limited | Cardiovascular | OBH | database entry | |
| IDx-DRDEN180001 · De Novo | IDx, LLC | Ophthalmic | PIB | database entry | |
| DR 800 with MUSICA DynamicK180589 · 510(k) | Agfa HealthCare N.V. | Radiology | JAA | database entry | |
| Acumen Hypotension Prediction IndexDEN160044 · De Novo | Edwards Lifesciences LLC | Cardiovascular | QAQ | database entry | |
| Tissue of Origin Test Kit-FFPEK173839 · 510(k) | Cancer Genetics, Inc. | Clinical Toxcicology | OIW | database entry | |
| Quantib BrainK173939 · 510(k) | Quantib BV | Radiology | LLZ | database entry | |
| iQMRK173605 · 510(k) | Medic Vision - Imaging Solutions Ltd | Radiology | LLZ | database entry | |
| DM-DensityK170540 · 510(k) | Densitas, Inc. | Radiology | LLZ | database entry | |
| ContaCTDEN170073 · De Novo | Viz.Al, Inc. | Radiology | QAS | database entry | |
| UNiD Spine AnalyzerK180091 · 510(k) | Medicrea International | Radiology | LLZ | database entry | |
| Arterys Oncology DLK173542 · 510(k) | Arterys Inc. | Radiology | LLZ | database entry | |
| Illumeo SystemK173588 · 510(k) | Philips Medical Systems Technologies, Ltd. | Radiology | LLZ | database entry | |
| CEREC Ortho SoftwareK171122 · 510(k) | Dentsply Sirona | Dental | PNN | database entry | |
| cNeuro cMRIK171328 · 510(k) | Combinostics Oy | Radiology | LLZ | database entry | |
| WAVE Clinical PlatformK171056 · 510(k) | Excel Medical Electronics, LLC | Cardiovascular | MWI | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.