Submission Details
| 510(k) Number | K161588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 08, 2016 |
| Decision Date | August 31, 2016 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Vscan Extend
Aug 2016
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K161588 is an FDA 510(k) clearance for the Vscan Extend, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on August 31, 2016, 84 days after receiving the submission on June 8, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Wauwatosa, WI · US
Tracey Ortiz
12 submissions
12 cleared
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