Cleared Special

Ziehm Vision RFD (K231692) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231692 · Ziehm Imaging GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
164d
Days
Class 2
Risk

K231692 is an FDA 510(k) clearance for the Ziehm Vision RFD. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ziehm Imaging GmbH (Nuremberg, DE). The FDA issued a Cleared decision on November 20, 2023 after a review of 164 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ziehm Imaging GmbH devices

Submission Details

510(k) Number K231692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2023
Decision Date November 20, 2023
Days to Decision 164 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 107d · This submission: 164d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 185
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K231692.
Ziehm Vision FD
K231700 · Ziehm Imaging GmbH · Dec 2023
ARTIS icono (VE30A)
K230950 · Siemens Medical Solutions USA, Inc. · Dec 2023
Ziehm Solo FD
K231669 · Ziehm Imaging GmbH · Dec 2023
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
K233200 · GEMSS HEALTHCARE CO., LTD. · Nov 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · GE Medical Systems SCS · Oct 2023
EXTRON 5
K230871 · DRTECH Corporation · Aug 2023