Submission Details
| 510(k) Number | K190186 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 01, 2019 |
| Decision Date | March 28, 2019 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
Mar 2019
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K190186 is an FDA 510(k) clearance for the Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 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 March 28, 2019, 55 days after receiving the submission on February 1, 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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