Cleared Traditional

K923524 - VOLUMETRIC RENDERING TECHNIQUE OPTION

K923524 is the FDA 510(k) clearance for VOLUMETRIC RENDERING TECHNIQUE OPTION by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 670-day FDA review.

K923524 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 1994
Decision
670d
Days
Class 2
Risk

K923524 is an FDA 510(k) clearance for the VOLUMETRIC RENDERING TECHNIQUE OPTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 670 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K923524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1992
Decision Date May 17, 1994
Days to Decision 670 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
563d slower than avg
Panel avg: 107d · This submission: 670d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K923524.
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COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
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K934832 · Heraeus Kulzer, Inc. · Dec 1993
HELICAT
K930090 · Elscint, Inc. · Mar 1993