Submission Details
| 510(k) Number | K243880 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2024 |
| Decision Date | June 17, 2025 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Jun 2025
Decision
181d
Days
Class 2
Risk
About This 510(k) Submission
K243880 is an FDA 510(k) clearance for the Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100), a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on June 17, 2025, 181 days after receiving the submission on December 18, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.
Device Classification
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1560 |
Manufacturer
Similar Devices — IYO System, Imaging, Pulsed Echo, Ultrasonic
All 889
K253898 · QT Imaging Holdings, Inc.
· Mar 2026
K253714 · Philips Image Guided Therapy Corporation
· Feb 2026
K253221 · Eieling Technology (Shenzhen) Limited
· Feb 2026
K250331 · Astrasono Technology Co., Ltd.
· Sep 2025
K250381 · DeepSight Technology, Inc.
· Aug 2025
K243227 · Accutome, Inc. Doing Business AS Keeler USA
· Jul 2025
More from Wuxi Hisky Medical...
View all
K250026
· IYN · Oct 2025
K243711
· OWN · Jul 2025
K200136
· IYO · Mar 2020
K173595
· IYO · Jun 2018