Submission Details
| 510(k) Number | K170856 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2017 |
| Decision Date | November 17, 2017 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
CMS600P2 B-Ultrasound Diagnostic System
Nov 2017
Decision
240d
Days
Class 2
Risk
About This 510(k) Submission
K170856 is an FDA 510(k) clearance for the CMS600P2 B-Ultrasound Diagnostic System, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on November 17, 2017, 240 days after receiving the submission on March 22, 2017. 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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