Ziehm Vision FD

FDA 510(k) K193230 · Ziehm Imaging GmbH

Substantially Equivalent

510(k) numberK193230

Submission

Device name
Ziehm Vision FD
Applicant
Ziehm Imaging GmbH
Nuremberg, DE
Received
November 25, 2019
Decision date
December 20, 2019
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OWB – Interventional Fluoroscopic X-Ray System
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1650
Specialty
Radiology

Interventional fluoroscopy

Other 510(k)s with product code OWB

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K254205Zenition 30OWB · Traditional Philips Medical Systems Nederland B.V.08/07/2026SE
K260607Shield System (Siemens 30x40)OWB · Special Radiaction , Ltd.07/31/2026SE
K253670SmartCT (R3.0 (L10))OWB · Abbreviated Philips Medical Systems B.V.07/10/2026SE
K252735C-beamOWB · Traditional Pulmera, Inc.05/22/2026SE
K252503Intelligent NROWB · Traditional Canon, Inc.04/30/2026SE
K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional Siemens Medical Solutions USA, Inc.04/24/2026SE
K253752ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional Siemens Medical Solutions USA, Inc.04/23/2026SE
K252229Belliger AceOWB · Traditional Genoray Co., Ltd.04/02/2026SE

More from Genoray Co., Ltd.

510(k)DeviceDecision
K243646Ziehm Solo FDOWB · Traditional 03/17/2025SE
K243735Ziehm Vision FDOWB · Traditional 03/13/2025SE
K243303Ziehm Vision RFD 3DOWB · Traditional 01/21/2025SE
K243328Ziehm Vision RFDOWB · Traditional 01/15/2025SE
K240099Ziehm Vision RFDOWB · Special 02/05/2024SE
K240020Ziehm Vision FDOWB · Special 01/30/2024SE
K234109Ziehm Solo FDOWB · Special 01/26/2024SE
K231700Ziehm Vision FDOWB · Special 12/15/2023SE
K231669Ziehm Solo FDOWB · Special 12/12/2023SE
K231692Ziehm Vision RFDOWB · Special 11/20/2023SE

Questions and answers

When was Ziehm Vision FD cleared by the FDA?

Ziehm Vision FD (K193230) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 25 days after the submission was received.

What is the product code of K193230?

The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.