27 devices · 26 companies · 2017
AI-enabled medical devices FDA authorized in 2017
27 devices authorized in 2017, 2017, from 26 companies across 16 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (26 of 27 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes authorized in 2017
- LLZ · System, Image Processing, Radiological12
- DSB · Plethysmograph, Impedance1
- DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency1
- DSH · Recorder, Magnetic Tape, Medical1
- IYO · System, Imaging, Pulsed Echo, Ultrasonic1
- IYN · System, Imaging, Pulsed Doppler, Ultrasonic1
- DPT · Probe, Blood-Flow, Extravascular1
- OBH · Monitor, Extracellular Fluid, Lymphedema, Extremity1
- JOY · Device, Automated Cell-Locating1
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1
- ONV · Electrical Impedance Spectrometer1
- DPS · Electrocardiograph1
- MNR · Ventilatory Effort Recorder1
- PTA · Genetic Variant Detection And Health Risk Assessment System1
- MYN · Analyzer, Medical Image1
- MXD · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)1
Panels
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Panel | Product code | FDA |
|---|---|---|---|---|---|
| Radiomics App v1.0K173420 · 510(k) | Microsoft Corp. | Radiology | LLZ | database entry | |
| SOZOK172507 · 510(k) | ImpediMed Limited | Cardiovascular | DSB | database entry | |
| Rooti Rx ECG Event Recorder, Rooti Link APP SoftK163694 · 510(k) | Rooti Labs Ltd. | Cardiovascular | DRG | database entry | |
| Infinitt PACS 7.0K172803 · 510(k) | Infinitt Healthcare Co.,Ltd. | Radiology | LLZ | database entry | |
| QuantraK163623 · 510(k) | HOLOGIC, INC. | Radiology | LLZ | database entry | |
| Peerbridge CorK171936 · 510(k) | Peerbridge Health INc. | Cardiovascular | DSH | database entry | |
| BladderScan Prime PLUS SystemK172356 · 510(k) | Verathon Incorporated | Radiology | IYO | database entry | |
| Clarius Ultrasound SystemK172385 · 510(k) | Clarius Mobile Health Corp. | Radiology | IYN | database entry | |
| NeuroQuantK170981 · 510(k) | CorTechs Labs, Inc | Radiology | LLZ | database entry | |
| SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0K163339 · 510(k) | SPECTRALMD, INC. | Cardiovascular | DPT | database entry | |
| SOZOK172122 · 510(k) | ImpediMed Limited | Cardiovascular | OBH | database entry | |
| Advanced RBC ApplicationK171315 · 510(k) | Cella Vision AB | Hematology | JOY | database entry | |
| QuantXDEN170022 · De Novo | Quantitative Insights, Inc | Radiology | POK | database entry | |
| NEVISENSEP150046 · PMA | SCIBASE AB | General and Plastic Surgery | ONV | database entry | |
| CardioLogs ECG Analysis PlatformK170568 · 510(k) | Cardiologs Technologies | Cardiovascular | DPS | database entry | |
| syngo Application SoftwareK170747 · 510(k) | Siemens Medical Solutions, USA, Inc. | Radiology | LLZ | database entry | |
| SmartTargetK170250 · 510(k) | SmartTarget, Ltd. | Radiology | LLZ | database entry | |
| UNiD Spine AnalyzerK170172 · 510(k) | MEDICREA INTERNATIONAL | Radiology | LLZ | database entry | |
| Lung VisionK163622 · 510(k) | BODY VISION MEDICAL LTD. | Radiology | LLZ | database entry | |
| MATRx plusK163665 · 510(k) | Zephyr Sleep Technologies | Anesthesiology | MNR | database entry | |
| AmCAD-UVK170069 · 510(k) | AmCad BioMed Corporation | Radiology | LLZ | database entry | |
| 23andMe Personal Genome ServiceDEN160026 · De Novo | 23andMe, Inc. | Immunology | PTA | database entry | |
| PowerLook Tomo Detection SoftwareP160009 · PMA | iCAD Inc | Radiology | MYN | database entry | |
| Reveal LINQK162855 · 510(k) | Medtronic, Inc. | Cardiovascular | MXD | database entry | |
| SIS SoftwareK162830 · 510(k) | Surgical Information Sciences, Inc. | Radiology | LLZ | database entry | |
| Quantib Brain 1.2K163013 · 510(k) | Quantib BV | Radiology | LLZ | database entry | |
| Arterys Cardio DLK163253 · 510(k) | ARTERYS INC. | Radiology | LLZ | database entry |
Every year in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.