ADVANTX LCN, ADVANTX LCLP— 510(k) K974367
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K974367 for ADVANTX LCN, ADVANTX LCLP, Substantially Equivalent on 1998-02-13. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- Product code
- Code IZI
- Device class
- Class 2
- Regulation
- 21 CFR 892.1600
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code IZI
view allMore clearances from GE Medical Systems
view allAdverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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 K974367
K-number listed on FDA's recall record- Z-0906-2017 — ADVANTX LCLP+
- Z-0907-2017 — ADVANTX LCN+
- Z-0763-2016 — Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA, INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
- Z-0021-2014 — GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974367.
Data sourced from openFDA. This site is unofficial and independent of the FDA.