Cleared Traditional

K032594 - ONE DIMENSIONAL WATER PHANTOM, WP 1D

K032594 is an FDA 510(k) clearance for ONE DIMENSIONAL WATER PHANTOM, manufactured by Wellhofer Dosimetrie. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K032594 · Wellhofer Dosimetrie · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
14d
Days
Class 2
Risk

K032594 is an FDA 510(k) clearance for the ONE DIMENSIONAL WATER PHANTOM, WP 1D. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Wellhofer Dosimetrie (Bartlett, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

FDA 510(k) Submission Details - K032594

510(k) Number K032594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date September 05, 2003
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.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 America, Inc.
STEFAN PREISS

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 - IYE Accelerator, Linear, Medical

All 724
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K032594 · ONE DIMENSIONAL WATER PHANTOM, WP 1D
Download PDF FDA Summary Wellhofer Dosimetrie