Cleared Traditional

K982349 - SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS

K982349 is an FDA 510(k) clearance for SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K982349 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1998
Decision
86d
Days
Class 2
Risk

K982349 is an FDA 510(k) clearance for the SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS. 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 September 30, 1998 after a review of 86 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.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K982349

510(k) Number K982349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date September 30, 1998
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 723
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K982349.
ASTEION CT SCANNER, TSX-021A
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PHILIPS TOMOSCAN CS
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SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
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VOLUMAX CT IMAGING SYSTEM
K982060 · Elscint, Inc. · Sep 1998
AQUILION CT SCANNER, MODEL TSX-101A
K982265 · Toshiba America Medical Systems, In.C · Aug 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004 · General Electric Co. · Aug 1998