INFX-8000V, V5.30— 510(k) K133535
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K133535 for INFX-8000V, V5.30, Substantially Equivalent on 2014-07-23. 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
- Traditional
- Location
- Tustin, CA, US
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 K133535
K-number listed on FDA's recall record- Z-0844-2018 — INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
- Z-0752-2016 — INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133535.
Data sourced from openFDA. This site is unofficial and independent of the FDA.