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FDA 510(k)

B-Ultrasound Diagnostic System

K-Number: K232895 · 2024-05-03

ApplicantContec Medical Systems Co.,Ltd
Decision Date2024-05-03
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

B-Ultrasound Diagnostic System is a medical device manufactured by Contec Medical Systems Co.,Ltd. It received FDA 510(k) clearance on 2024-05-03 under approval number K232895. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B-Ultrasound Diagnostic System?

B-Ultrasound Diagnostic System is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Contec Medical Systems Co.,Ltd. The 510(k) number is K232895.

When was B-Ultrasound Diagnostic System approved by the FDA?

B-Ultrasound Diagnostic System received FDA 510(k) clearance on 2024-05-03, under approval number K232895.

What company makes B-Ultrasound Diagnostic System?

B-Ultrasound Diagnostic System is manufactured by Contec Medical Systems Co.,Ltd.

What is the FDA product code for B-Ultrasound Diagnostic System?

The FDA product code for B-Ultrasound Diagnostic System is IYO.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07608614 Sleep and Performance RECRUITING

Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Other Devices by Contec Medical Systems Co.,Ltd

K152863Portable ECG Monitor K170856CMS600P2 B-Ultrasound Diagnostic System K170954Portable ECG Monitor K171360CONTEC™ Electrocardiograph K201980Infrared Thermometer K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor

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Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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