WS80A Diagnostic Ultrasound System
by Samsung Medison Co., Ltd. 4 variants
510(k) K171070
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171070 | Date9 Aug 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The WS80A Diagnostic Ultrasound System is a diagnostic ultrasound system designed for imaging internal body structures in medical settings. It is a multi-specialty ultrasound system used for diagnostic purposes, providing high-quality images to support clinical assessment.
The system is supplied as a non-sterile, reusable device intended for use by qualified medical personnel in clinical environments. It is manufactured by Samsung Medison Co., Ltd. and has received FDA 510(k) clearance under K-number K171070 with product code IYN, classified as substantially equivalent to a predicate device.
Other devices from Samsung Medison Co., Ltd.
Questions
AI-generated answers, 26 Sep 2026
What is the WS80A Diagnostic Ultrasound System used for?
The WS80A Diagnostic Ultrasound System is designed for imaging internal body structures in medical settings and is used for diagnostic purposes across multiple specialties to support clinical assessment with high-quality images.
Is the WS80A Diagnostic Ultrasound System sterile or non-sterile, and is it intended for single-use or reuse?
The WS80A Diagnostic Ultrasound System is supplied as a non-sterile device and is intended for reuse by qualified medical personnel in clinical environments, meaning it can be cleaned and used multiple times following appropriate reprocessing procedures.
What regulatory clearance does the WS80A Diagnostic Ultrasound System have?
The WS80A Diagnostic Ultrasound System has received FDA 510(k) clearance under K-number K171070, with product code IYN, and was determined to be substantially equivalent to a predicate device.