Cleared Traditional

K950981 - ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650

K950981 is an FDA 510(k) clearance for ULTRA-PRO ULTRASOUND SCANNING TABLE MOD..., manufactured by Biodex Medical Systems, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K950981 · Biodex Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
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Apr 1995
Decision
31d
Days
Class 2
Risk

K950981 is an FDA 510(k) clearance for the ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on April 3, 1995 after a review of 31 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 Biodex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K950981

510(k) Number K950981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date April 03, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K950981.
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K944987 · Philips Medical Systems (Cleveland), Inc. · Nov 1994