Cleared Traditional

K041521 - VOLUME VIEWER PLUS

K041521 is an FDA 510(k) clearance for VOLUME VIEWER PLUS, manufactured by General Electric Medical Systems. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K041521 · General Electric Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
14d
Days
Class 2
Risk

K041521 is an FDA 510(k) clearance for the VOLUME VIEWER PLUS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by General Electric Medical Systems (Waukesha, US). The FDA issued a Cleared decision on June 22, 2004 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 - K041521

510(k) Number K041521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date June 22, 2004
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.

JAK Device Classification - Class 2, Special Controls

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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.
TAMAS BORSAI

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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All 797
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K041521 · VOLUME VIEWER PLUS
Download PDF FDA Summary General Electric Medi…