Cleared Traditional

K914351 - CLINITRON C-10 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914351 · Ssi Medical Services, Inc. · Radiology device
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Feb 1992
Decision
140d
Days
Class 2
Risk

K914351 is an FDA 510(k) clearance for the CLINITRON C-10. Classified as Table, Radiographic, Stationary Top (product code IXQ), Class II - Special Controls.

Submitted by Ssi Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ssi Medical Services, Inc. devices

Submission Details

510(k) Number K914351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1991
Decision Date February 14, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXQ Table, Radiographic, Stationary Top
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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.