Cleared Traditional

K945163 - ECHOCARDIOGRAPHY

K945163 is an FDA 510(k) clearance for ECHOCARDIOGRAPHY, manufactured by Tri W-G, Inc.. The device is a Class 1 General Hospital device with product code LGX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K945163 · Tri W-G, Inc. · General Hospital
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Feb 1995
Decision
119d
Days
Class 1
Risk

K945163 is an FDA 510(k) clearance for the ECHOCARDIOGRAPHY. Classified as Table, Examination, Medical, Powered (product code LGX), Class I - General Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 119 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tri W-G, Inc. devices

FDA 510(k) Submission Details - K945163

510(k) Number K945163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1994
Decision Date February 17, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

LGX Device Classification - Class 1, General Controls

Product Code LGX Table, Examination, Medical, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LGX Table, Examination, Medical, Powered

Devices cleared under the same product code (LGX) and FDA review panel - the closest regulatory comparables to K945163.
POWER EXAMINATION TABLE MODEL # 411
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K810900 · Sybron Corp. · Apr 1981