Cleared Traditional

K971054 - OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS

K971054 is an FDA 510(k) clearance for OSTEO CT FOR THE SOMATOM AR FAMILY AND ..., 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 81-day FDA review.

K971054 · Siemens Medical Solutions USA, Inc. · Radiology device
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Jun 1997
Decision
81d
Days
Class 2
Risk

K971054 is an FDA 510(k) clearance for the OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS. 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 June 13, 1997 after a review of 81 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 - K971054

510(k) Number K971054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date June 13, 1997
Days to Decision 81 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
26d faster than avg
Panel avg: 107d · This submission: 81d
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 K971054.
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
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K971717 · Siemens Medical Solutions USA, Inc. · Sep 1997
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K970999 · Sony Medical Systems · May 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · GE Medical Systems · Apr 1997