Submission Details
| 510(k) Number | K200136 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 21, 2020 |
| Decision Date | March 17, 2020 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Shear Wave Quantificational Ultrasound Diagnostic System
Mar 2020
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K200136 is an FDA 510(k) clearance for the Shear Wave Quantificational Ultrasound Diagnostic System, 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 March 17, 2020, 56 days after receiving the submission on January 21, 2020. 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
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