INFX-8000V with Wireless Footswitch— 510(k) K143225
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K143225 for INFX-8000V with Wireless Footswitch, Substantially Equivalent on 2015-01-09. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- 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
- Special
- Location
- Otawara-Shi, Tochigi-Ken, JP
Recent devices under product code OWB
view allMore clearances from Toshibamedical Systems Corporation
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 K143225
K-number listed on FDA's recall record- Z-0752-2016 — INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
- Z-1394-2015 — INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143225.
Data sourced from openFDA. This site is unofficial and independent of the FDA.