Cleared Traditional

Ziehm 8000 (K190497) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190497 · Ziehm Imaging GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
265d
Days
Class 2
Risk

K190497 is an FDA 510(k) clearance for the Ziehm 8000. 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, 2019 after a review of 265 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ziehm Imaging GmbH devices

Submission Details

510(k) Number K190497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2019
Decision Date November 20, 2019
Days to Decision 265 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 107d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Ziehm Imaging, Inc.
Steve Seeman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K190497.
C015
K192182 · Micronica Srl · Jan 2020
Ziehm Vision FD
K193230 · Ziehm Imaging GmbH · Dec 2019
uMC 560i
K183144 · Shanghai United Imaging Healthcare Co., Ltd. · Dec 2019
ARTIS icono
K190768 · Siemens Medical Solutions USA, Inc. · Sep 2019
MobileRay Pulse SE Digital Imaging System
K191503 · Portavision Medical, LLC · Sep 2019
ARCO FP
K182086 · A.T.S. Applicazione Tecnologie Speciali S.R.L. · Aug 2019