Submission Details
| 510(k) Number | K061129 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 2006 |
| Decision Date | June 01, 2006 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
Jun 2006
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K061129 is an FDA 510(k) clearance for the GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on June 1, 2006, 38 days after receiving the submission on April 24, 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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