GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000— 510(k) K061129
Substantially EquivalentGeneral Electric Co.
FDA 510(k) clearance K061129 for GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000, Substantially Equivalent on 2006-06-01. Applicant: General Electric Co.. Device class: 2.
Clearance details
- Applicant
- General Electric Co.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Wauwatosa, WI, US
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More clearances from General Electric Co.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K061129
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061129.
Data sourced from openFDA. This site is unofficial and independent of the FDA.