INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500— 510(k) K040050
Substantially EquivalentGe Medical Systems Navigation and Visualization IN
FDA 510(k) clearance K040050 for INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500, Substantially Equivalent on 2004-03-24. Applicant: Ge Medical Systems Navigation and Visualization IN. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Navigation and Visualization IN
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code LLZ
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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 K040050
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 K040050.
Data sourced from openFDA. This site is unofficial and independent of the FDA.