DISCOVERY IGS 740— 510(k) K133278
Substantially EquivalentGE Medical Systems SCS
FDA 510(k) clearance K133278 for DISCOVERY IGS 740, Substantially Equivalent on 2014-04-24. 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 K133278
K-number listed on FDA's recall record- Z-2388-2018 — Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
- Z-1707-2016 — GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
- Z-1975-2015 — GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- 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-0452-2015 — Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133278.
Data sourced from openFDA. This site is unofficial and independent of the FDA.