Cleared Traditional

K161976 - Ziehm Solo FD

K161976 is an FDA 510(k) clearance for Ziehm Solo FD, manufactured by Ziehm Imaging GmbH. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K161976 · Ziehm Imaging GmbH · Radiology device
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Oct 2016
Decision
80d
Days
Class 2
Risk

K161976 is an FDA 510(k) clearance for the Ziehm Solo FD. 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 October 6, 2016 after a review of 80 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ziehm Imaging GmbH devices

FDA 510(k) Submission Details - K161976

510(k) Number K161976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date October 06, 2016
Days to Decision 80 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
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

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.
RICHARD L. WESTRICH

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.

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