OWB
SyncVision System
- Advisory panel
- Radiology
- Total cleared
- 316
Adverse 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 →
Recent clearances under product code OWB
1–100 of 316- K252229 — BELLIGER ACE
- K252099 — Trinias
- K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- K252500 — CARA System
- K251992 — ArmSure Fluoroscopic Positioning System
- K254186 — Azurion R3.1
- K252068 — MC2 Portable X-ray System
- K251893 — SKAN C PULSAR
- K251199 — Allia Moveo
- K250241 — Cios Select
- K251827 — Azurion R3.1
- K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- K251523 — Cios Spin
- K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
- K250660 — LUMINOS Q.namix T; LUMINOS Q.namix R
- K251520 — Cios Alpha; Cios Flow
- K243884 — TAVIPILOT
- K250010 — EXTRON 3; EXTRON 5; EXTRON 7
- K243411 — Diagnostic X-ray System
- K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X)
- K250282 — Persona C HR
- K243376 — uAngio AVIVA CX
- K234067 — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)
- K243646 — Ziehm Solo FD
- K243735 — Ziehm Vision FD
- K243446 — 3DXR
- K243303 — Ziehm Vision RFD 3D
- K243328 — Ziehm Vision RFD
- K241567 — MC2 Portable X-ray System
- K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
- K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
- K233230 — See Factor CT3
- K240465 — O-arm O2 Imaging System
- K240199 — IntraOp Alignment System
- K240224 — Zenition 90
- K232298 — DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
- K233748 — CIARTIC Move (VB10)
- K232420 — Zenition 30
- K240099 — Ziehm Vision RFD
- K240020 — Ziehm Vision FD
- K234109 — Ziehm Solo FD
- K230949 — ARTIS pheno (VE30A)
- K231700 — Ziehm Vision FD
- K230950 — ARTIS icono (VE30A)
- K231669 — Ziehm Solo FD
- K231692 — Ziehm Vision RFD
- K233200 — XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
- K232344 — Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- K230871 — EXTRON 5; EXTRON 7
- K230787 — Oscar 15 & Oscar 15i
- K231701 — Ziehm Vision RFD 3D
- K222998 — F3
- K230185 — ANT-X System
- K221344 — nView s1 with nav option
- K223410 — Cios Select (VA21) Flat Panel
- K223409 — Cios Select (VA21) Image Intensifier
- K213768 — Bolt Navigation System
- K221281 — Multitom Rax
- K222070 — EndoNaut
- K222080 — Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
- K222625 — Shield System
- K220342 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
- K221230 — TRON
- K221922 — Trinias
- K221516 — ARTIS icono (Ceiling Configuration)
- K220409 — ARTIS pheno (VE21) System
- K220432 — ARTIS icono (VE21) System
- K221335 — D²RS and D²RS 9090
- K220311 — Cardiovascular Angiography System
- K220946 — SURGIVISIO Device
- K212159 — Shield System
- K220627 — SURGIVISIO Device
- K211780 — ZEN-2090 Turbo
- K212212 — Multitom Rax with True2scale Body Scan Option
- K213479 — D²RS and D²RS 9090
- K212442 — Cydar EV (Series B) and Cydar EV Maps
- K213455 — ControlRad Select Model Z
- K212336 — Soteria.AI
- K212956 — FDR Cross (DR-XD 3000)
- K212523 — VFSS Pro Mobile Digital Imaging System
- K211064 — nView s1 with nav option
- K212813 — Zenition 70
- K212557 — Virtual C DRF-NEO Digital Imaging System
- K212383 — EndoNaut
- K211777 — ARCO FP-S
- K210912 — Excelsius3D
- K211782 — ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
- K211191 — Virtual C DRF Digital Imaging System
- K203535 — Trinias
- K210900 — Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
- K203623 — StentBoost Mobile
- K202547 — Surgivisio system
- K210309 — Cios Select (VA21) Flat Panel
- K210307 — Cios Select (VA21) Image Intensifier
- K201743 — ClarifEye R1.0, ClarifEye Needle
- K201583 — SmartCT R1.0
- K210054 — Cios Spin
- K210055 — Cios Alpha
- K202431 — ControlRad Select Model Z
- K203281 — Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
Data sourced from openFDA. This site is unofficial and independent of the FDA.