GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM— 510(k) K113403
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K113403 for GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM, Substantially Equivalent on 2012-02-14. Applicant: GE Medical Systems SCS. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems SCS
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buc, FR
Recent devices under product code OWB
view allMore clearances from GE Medical Systems SCS
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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 K113403
K-number listed on FDA's recall record- Z-2386-2018 — Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
- Z-1706-2016 — GE Healthcare, Discovery IGS 730. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
- Z-0966-2015 — GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.
- Z-2253-2013 — GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.