Cleared Traditional

KOORDINAT M (K951176) - FDA 510(k) Clearance

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

K951176 · Siemens Medical Solutions USA, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
36d
Days
Class 2
Risk

K951176 is an FDA 510(k) clearance for the KOORDINAT M. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 20, 1995 after a review of 36 days - a notably fast clearance cycle.

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: 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 K951176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1995
Decision Date April 20, 1995
Days to Decision 36 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
71d faster than avg
Panel avg: 107d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
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.

Regulatory Peers - IXR Table, Radiographic, Tilting

All 76
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K951176.
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K882019 · General Electric Co. · May 1988
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
TABLE, X-RAY, RFX CLASSICAL
K760466 · General Electric Co. · Aug 1976