Cleared Traditional

K903377 - COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OP...

K903377 is the FDA 510(k) clearance for COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OP... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAD) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K903377 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 1990
Decision
53d
Days
Class 2
Risk

K903377 is an FDA 510(k) clearance for the COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 21, 1990 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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

Submission Details

510(k) Number K903377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date September 21, 1990
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 13
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