Submission Details
| 510(k) Number | K192791 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2019 |
| Decision Date | November 27, 2019 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Diagnostic Ultrasound System
Nov 2019
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K192791 is an FDA 510(k) clearance for the Diagnostic Ultrasound System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on November 27, 2019, 58 days after receiving the submission on September 30, 2019. 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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