Submission Details
| 510(k) Number | K060542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 2006 |
| Decision Date | March 31, 2006 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
Mar 2006
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K060542 is an FDA 510(k) clearance for the GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on March 31, 2006, 30 days after receiving the submission on March 1, 2006. 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
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