Cleared Traditional

K010942 - U04

K010942 is the FDA 510(k) clearance for U04 by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code OWB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K010942 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
14d
Days
Class 2
Risk

K010942 is an FDA 510(k) clearance for the U04. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 12, 2001 after a review of 14 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K010942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2001
Decision Date April 12, 2001
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Tuv Rheinland of North America, Inc.

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 239
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K010942.
INNOVA 4100
K023178 · Ge Medical Systems, Inc. · Nov 2002
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc. · Oct 2002
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · Toshiba America Medical Systems, In.C · Nov 2001
PHILIPS BV PULSERA/ENDURA
K010435 · Philips Medical Systems, Inc. · Mar 2001
PHILIPS INTEGRIS ALLURA
K002016 · Philips Medical Systems North America, Inc. · Sep 2000
LCV+ VERSION 2
K993037 · Ge Medical Systems, Inc. · Feb 2000